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VA National Center for Patient Safety

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Alerts and Advisories

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NCPS develops and publishes Patient Safety Alerts and Advisories that concern specific issues relating to equipment, medications, and procedures that might cause harm to patients.

Alerts communicate urgent notices that require immediate and specific action(s) by specific parties by a specified deadline. Advisories communicate recommendations and are more general in nature, and their implementation may be subject to local judgment.

Most alerts and advisories are shared with the public; however, when the information is relevant only to VA employees, those Alerts or Advisories are placed on NCPS’ Intranet site; therefore, this is not a complete list of all Alerts and Advisories.

2015 | 2014 | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007
2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 |

2014

Date Level Product/Device
2014-11-08 Alert

Table Tipping Risk with GE Healthcare Infinia Nuclear Medicine Imaging Systems.

AL14-08

2013

Date Level Product/Device
2013-06-07 Alert

GE dual-head gamma cameras: Unintended movement can cause serious injury or death.

Please note: This Patient Safety Alert affects a more comprehensive list of dual-headed gamma cameras than in previous communications. AL 13-08 amended by AL13-08 Addendum and AL 13-08 Addendum #2.

AL13-08

2013-01-24 Alert

International Normalized Ratio (INR) values may display incorrectly in VistA/CPRS Anticoagulation Management Tool (AMT) software

AL13-05

2013-01-15 Alert

Incorrect eye surgery adverse events in Veterans Health Administration facilities

AL13-03

2013-01-14 Alert

Multi-Dose Pen Injectors

AL13-04

2012

Date Level Product/Device
2012-11-15 Alert

Increased risk of metabolic alkalosis with acetate-containing dialysis acid concentrates that can cause cardiac arrest, arrhythmias and low blood pressure in dialysis patients

AL13-02

2012-10-02 Alert

High vacuum/high flow suction devices, used inappropriately, have resulted in patient injuries and death

AL13-01

2012-05-16 Alert

Certain lots of Ethicon HARMONIC® HPBLUE and HP054 hand pieces are not compatible with the Ethicon HARMONIC® Generator Model 300 (GEN04)

AL12-08

2012-04-10 Alert

Incorrect Patient Information Displayed in VA's Computerized Patient Record System (CPRS) v28

AL12-07

2012-04-09 Advisory

Plastic cards can be used to disable locks in inpatient mental health and Emergency Department (ED) settings treating patients who have the potential for unpredictable or unsafe behavior (e.g., violence, suicide, etc.) and are not on 1:1 observation

AD12-02

2012-03-22 Advisory

Disassembly of wheelchairs in inpatient mental health and emergency department (ED) settings treating patients who have the potential for unpredictable or unsafe behavior (e.g., violence, suicide, etc.) and are not on 1:1 observation

AD12-01

2012-02-23 Alert

Electronic Order Check(s) may not trigger appropriately for drug-allergy interactions due to updates to drug class files in Veterans Health Information Systems and Technology Architecture (VistA)/ Computerized Patient Record System (CPRS)

*The software referenced in AL12-04* includes VA Computerized Patient Record System (CPRS) v1.0.28.24, Veterans Health Information Systems and Technology Architecture (VistA) Inpatient Medication Package v5.0, VistA Outpatient Pharmacy Package v7.0, and VistA Adverse Reaction Tracking v4.0.

AL2-04*

2012-02-10 Alert

Issues identified with Identity Management in commercial Clinical Information Systems/Anesthesia Record Keeping (CIS/ARK) systems in use at VA facilities.

AL12-02

2011

Date Level Product/Device
2011-12-19 Alert

Software upgrade to resolve Bayer Viterion V100 BGM Home Telehealth hub device not transmitting all of Roche Accu-Chek Aviva blood glucose meters' data via Roche infrared peripheral.

Replaces and supersedes Patient Safety Alert AL11-03 issued April 27, 2011

AL12-01 FAQs Revised 1/5/2012

AL12-01

2011-09-12 Alert

Look-Alike Hemodialysis Solutions

AL11-09

2011-06-28 Alert

Potential anchor points for hanging in mental health units treating actively suicidal patients and other areas treating or holding suicidal patients that are not on 1:1 observation (e.g., psychiatric holding areas in emergency departments)

AL11-08

2011-06-28 Alert

Furniture floor guards in mental health units treating actively suicidal patients and other areas treating or holding suicidal patients that are not on 1:1 observation (e.g., psychiatric holding areas in emergency departments)

AL11-07

2011-06-28 Alert

Walker used to barricade a sleeping room door on a locked inpatient mental health unit treating currently suicidal patients

AL11-06

2011-04-08 Alert

Use of elastic-hemmed fitted bed sheets in mental health units and other units holding or treating actively suicidal patients

FAQS for AL11-02 Revised 4/19/2011

AL11-02

2010

Date Level Product/Device
2010-10-25 Alert

Standardized Process for Insulin Orders when used in Patient Controlled Insulin Pumps

*The software referenced in AL11-01* includes VA Computerized Patient Record System (CPRS) v1.0.27.90, Bar Code Medication Administration (BCMA) v3.0.32.47, and uses Veterans Health Information Systems and Technology Architecture (VistA) Inpatient Medication Package v5.0.

AL11-01*

2010-07-07 Alert

Hepatitis C virus (HCV) testing using Novartis Chiron RIBA HCV 3.0 Strip Immunoblot Assay (SIA) reagents

AL10-14

2010-07-07 Alert

Redsense® Dialysis Alarm for Patients Undergoing Needle Access Procedures

FAQS for AL10-13 Revised 10/29/2010

AL10-13

2010-05-13 Alert

Philips IntelliVue Non Invasive Blood Pressure (NIBP) monitors may display only Mean Arterial Pressure (MAP) results: Models MP20/30/40/50/60/70/80/90

AL10-11

2010-05-04 Alert

Hospital-grade power cords, manufactured by Electri-Cord and sold to medical equipment manufacturers

AL10-10

2010-03-22 Alert

Ceiling mounted patient lift installations

AL10-07

2010-02-17 Advisory

Misidentification of patient resulting in delay of surgery

AD10-01

2010-02-03 Alert

Fresenius HemaClip used during dialysis

AL10-05

2009

Date Level Product/Device
2009-12-14 Alert

Possible blood contamination in hemodialysis machines

AL10-04

2009-10-06 Alert

Attempted hanging from a door in a locked mental health unit

AL10-03

2009-10-01 Alert

Glucose Monitoring Test Strips that utilize Glucose Dehydrogenase Pyrroloquinoline Quinone (GDH-PQQ) methodology may give falsely elevated glucose results

AL10-01

2009-09-02 Alert

Operable exterior windows in locked inpatient mental health units

AL09-25

2009-08-06 Alert

Medtronic SynchroMed II Implantable Drug Infusion Pump; Models: 8637-20 and 8637-40

AL09-24

2009-07-10 Advisory

Alarms on bedside physiological monitors

AD09-09

2009-06-16 Alert

Philips IntelliVue G1/G5 Anesthesia Gas Modules: Model Numbers M1013A and M1019A and Dräger Apollo Anesthesia Machines and Multigas Monitor: Model SCIO

AL09-23

2009-06-08 Alert

Physician Advisory issued by Medtronic Inc. on subsets of: Kappa 600/700/900 series dual chamber and single chamber pacemakers and Sigma 100/200/300 series dual chamber and single chamber cardiac pacemakers

AL09-22

2009-05-04 Alert

Arjo Carendo Shower Chair Model BIB 2003-01 or BIB2003-01KT

AL09-21

2009-04-22 Alert

Transvaginal Placement of Surgical Mesh

AL09-20

2009-04-03 Alert

CPRS — Changing Medication Schedule may Leave Incorrect Medication Administration Times

AL09-19

2009-03-24 Alert

AEDPlus Public Access Automated External Defibrillators (AEDs), manufactured by Zoll.

AL09-17

2009-03-05 Alert

Cylinder Valve Explodes from Oxygen Cylinder supplied with Rotarex/Ceodeux Post Type Cylinder Valve

AL09-16

2009-03-03 Alert

Medication Safety- Insulin U-500 Safety Enhancements

AL09-15

2009-02-20 Alert

Medtronic InFuse Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

AL09-13

2009-02-19 Advisory

Cardinal Health’s Alaris System Infusion Pumps

AD09-07

2008

Date Level Product/Device
2008-12-30 Advisory

Suicide attempt in the Emergency Room (ER)

AD09-05

2008-12-22 Alert

Improper set-up and reprocessing of flexible endoscope tubing and accessories

AL09-07

2008-11-20 Alert

Maxi Move patient lifts with "Lock and Load" system (Combi Hanger): Manufactured by Arjo between November 2005 and April 2008

AL09-06

2008-10-27 Alert

Baxter Single Strength Dosing Card for BREVIBLOC Premixed Injection (esmolol HCl) 2,500 mg/250 mL (10 mg/mL) Ready-to-use-Bags, 250 mL bags

AL09-03

2008-10-24 Alert

Medtronic Neuromodulation Sutureless Connector Catheters used with SynchroMed and IsoMed implantable infusion pumps:

INDURA One-Piece (1P) Intrathecal Catheters, Model 8709SC
Intrathecal Catheters, Model 8731SC
Sutureless Pump Connector Revision Kit, Model 8578
Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC

AL09-02

2008-10-21 Advisory

Methicillin-resistant Staphylococcus aureus (MRSA) contamination in an orthopedic clinic room

AD09-03

2008-10-21 Advisory

Bleeding episodes during dialysis

AD09-02

2008-10-10 Alert

Shower curtains in locked mental health units

AL09-01

2008-03-31 Alert

Improper reprocessing of flexible endoscope biopsy valves

AL08-13

2008-03-12 Alert

STERIS C1160 Universal Flexible Processing Trays used with the STERIS System 1 Sterile Processing Systems

AL08-11

2008-01-25 Alert

Implant orientation of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Devices (CRT-Ds) manufactured by Boston Scientific Corporation’s Cardiac Rhythm Management Division, previously under the name Guidant.

AL08-07

2007

Date Level Product/Device
2007-12-21 Alert

FDA CLASS II recall of Boston Scientific Corporation's Cardiac Rhythm Management Division (previously called Guidant) Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds).

AL08-06

2007-12-07 Advisory

Positive displacement, needle-free intravascular connector valves

Positive displacement, needle-free intravascular connector valves

AD08-01

2007-11-29 Alert

Model 8100 infusion pump modules shipped before September 27, 2007; a component of the Alaris Medley infusion pump system, distributed by Cardinal Health.

AL08-04

2007-10-25 Alert

Sprint Fidelis® Defibrillation Leads, manufactured by Medtronic

AL08-02

2007-10-23 Alert

Medtronic SynchroMed EL implantable infusion pump; models: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18.

AL08-01

2007-04-18 Alert

Boston Scientific Corporation's Cardiac Rhythm Management Division (previously called Guidant) recall of Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds).

AL07-07

2007-02-16 Alert

Privacy curtains in locked mental health wards

AL07-04

2007-02-14 Advisory

Daylight Savings Time (DST) changes

Daylight Savings Time (DST) changes

AD07-04

2007-01-31 Advisory

Reprocessing of resectoscope system’s working elements

Reprocessing of resectoscope system's working elements

AD07-03

2007-01-08 Advisory

Gemini PC series infusion pumps manufactured by Alaris, formerly IMED

Gemini PC series infusion pumps manufactured by Alaris, formerly IMED

AD07-01

2006

Date Level Product/Device
2006-08-30 Alert

All models of Alaris® SE infusion pumps — formerly the Signature Edition® Infusion System. Alaris is a subsidiary of Cardinal Health, Inc.

AL06-16

2006-07-24 Alert

Sealed, lead-acid batteries for external defibrillators supplied by non-OEM (Original Equipment Manufacturer) or second source suppliers. Second source suppliers include Alpha Source, Anybattery, R&D Batteries and Unipower, among others.

AL06-15

2006-06-28 Alert

Boston Scientific/Guidant Recall

AL06-14

2006-04-06 Alert

Mix-up (wrong route of administration) of bladder irrigation with intravenous (IV) infusions

AL06-12

2006-04-03 Alert

Transrectal ultrasound transducer assembly, Models 8808 and 8551, manufactured by B-K Medical Systems, Inc., Wilmington, MA

AL06-11

2006-02-08 Alert

Cessation of Topical Spray Benzocaine Usage to Anesthetize the Surfaces of the Nasopharynx, Oropharynx, Laryngotracheal Region and Airway

Attachment A Updated 8/11/06

AL06-09

2006-01-10 Advisory

Ipump Pain Management System, APII Infusion Pump and PCAII Infusion Pump, manufactured by Baxter Healthcare Corporation.

AD06-03

2006-01-09 Alert

Physician Advisory issued by Medtronic Inc. on the Sigma Series single and dual chamber pacemakers (SD203, SD303, SDR203, SDR303, SDR306, SVDD303, SS103, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVVI103)

AL06-08

2005

Date Level Product/Device
2005-12-21 Alert

Injector connector relays on patient tables manufactured by Philips Medical, table models AD5 and AD6 used with the Integris, Integris Allura and Allura Xper x-ray systems.)

AL06-06

2005-11-01 Alert

Heat maintainers for Stellant CT Injector Systems, manufactured by MEDRAD, Inc. Part numbers for the heat maintainers are 3007871, 3007872, 3009707 and 3009708. (Note: Part numbers for the Stellant injector systems are 3007301, 3010432, 3007300 and 3010091.)

AL06-04

2005-06-08 Alert

Guidant Model 1861 Ventak Prizm 2 DR, Implantable Cardioverter-Defibrillators (ICD) manufactured before November 2002

AL05-13

2005-05-31 Alert

Blood Glucose Monitors (Glucometers), models OneTouch, Ultra, InDuo, and OneTouch FastTake manufactured by LifeScan, Inc.

AL05-11

2005-03-29 Alert

Enclosed Bed systems manufactured by Vail Products Inc, models: 500, 1000, and 2000.

AL05-09

2005-02-28 Alert

Louvered heating, ventilating and air conditioning (HVAC) grilles in locked Behavioral Health Units.

AL05-06

2005-01-12 Alert

Nellcor pulse oximeters, model 595 and limited quantities of models 395, 295 and 290

Nellcor 595 Alert

2005-01-10 Advisory

Depression Screening for Veteran Patients Recently Separated from Active Military Duty

Depression Screening Advisory

2004

Date Level Product/Device
2004-11-09 Advisory

Electro-magnetic Interference (EMI) from the use of two-way hand held radios/ walkie-talkies in close proximity to medical devices.

EMI Advisory

2004-10-21 Advisory

ALARIS (IMED) Gemini Infusion Pumps

Alaris Gemini Advisory

2004-07-02 Alert

Failure of medical alarm systems using paging technology to notify clinical staff

Alarm Paging Alert

2004-06-02 Alert

Minor Surgery/Exam lights: CoolSpot™ and Outpatient® Fleximount™ Single Ceiling and Track Mount with Single Trolley manufactured by Burton Medical before August 2000.

Burton Lights Alert

2004-04-28 Alert

Implantable Cardioverter Defibrillators (ICD) manufactured by Medtronic

Medtronic ICD Alert

2004-04-28 Advisory

Drug File View from CPRS

CPRS Drug File Advisory

2004-04-05 Alert

Oxygen Utility System

Oxygen Utility System Alert

2004-02-13 Alert

Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes

Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes

2003

Date Level Product/Device
2003-11-04 Alert

J&J Cordis CypherTM Sirolimus-Eluting Coronary Stent

J&J Cordis CypherTM Sirolimus-Eluting Coronary Stent

2003-07-21 Alert

Soft Skin protective sleeve

Soft Skin protective sleeve

2003-07-14 Alert

Power cords for Hill-Rom Century+ electric beds

Power cords for Hill-Rom Century+ electric beds

2003-06-18 Alert

Decimal point display - Abbott APM II pump

Decimal point display - Abbott APM II pump

2003-06-18 Alert

In-line air filter requirement for Abbott Pumps

In-line air filter requirement for Abbott Pumps

2003-03-06 Advisory

Olympus EXERA™ Gastrointestinal Endoscopes

Olympus EXERA Gastrointestinal Endoscopes

2002

Date Level Product/Device
2002-09-30 Advisory

Cochlear Implant Risk

Cochlear Implant Risk

2002-07-22 Advisory

SSCOR Suction Pumps

SSCOR Suction Pumps

2002-05-28 Advisory

ADDENDUM to Advisory for Allegiance Irrigation Kits

ADDENDUM to Advisory for Allegiance Irrigation Kits

2002-02-27 Advisory

Potential for incorrectly attaching Allegiance Irrigation Kit caps to Foley catheters

Potential for incorrectly attaching Allegiance Irrigation Kit caps to Foley catheters

2002-01-23 Alert

Zoll M Series defibrillators and M Series Automated External Defibrillators

Zoll M Series defibrillators and M Series Automated External Defibrillators

2001

Date Level Product/Device
2001-08-15 Advisory

Risperidone oral medication syringe (pipette)

Risperidone oral medication syringe (pipette)

2001-07-13 Alert

Bed Rail Entrapment

Bed Rail Entrapment

2001-02-05 Alert

Magnetic Resonance Imaging (MRI) systems

Magnetic Resonance Imaging (MRI) systems

2000

Date Level Product/Device
2000-01-03 Advisory

Alert Ventilators - All Makes/Models

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