FDA Adverse Event Other Summary report: N

CAREFUSION ALARIS PUMPS

MDR report key: 4516236 · Received February 9, 2015

Report

Report Number
MW5040701
Event Type
Other
Date Received
February 9, 2015
Report Date
December 10, 2014
Manufacturer
CAREFUSION
Product Code
FRN
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT HAS BEEN DISCOVERED THAT CAREFUSION ALARIS PUMPS HAVE NOT VALIDATED THE REDESIGNED COVIDIEN SYRINGES FOR USE IN ALARIS PUMPS. OUR ORGANIZATION HAS CONTACTED ALARIS ABOUT WHEN THIS VALIDATION WILL BE COMPLETED. FEEDBACK FROM ALARIS STATES UP TO 8 WEEKS AND SOME AT ALARIS STATED THE PROCESS HAS NOT BEEN STARTED AS OF YET. OUR ORGANIZATION HAD MOVED TO COVIDIEN SYRINGES A FEW YEARS BACK. THE SYRINGE HAS/HAD SOME DESIGN FLAWS SUCH AS FINGER FLANGE IS TOO SMALL AND PLUNGER PULLS OUT EASILY FROM BARREL POSING POTENTIAL FOR RISK TO PATIENTS AND EMPLOYEES E.G. CHEMOTHERAPY AGENTS. THE COMPANY APPARENTLY DID A REDESIGN TO ELIMINATE THE FLAWS. THIS REDESIGN OF COURSE WOULD REQUIRE A VALIDATION OF THE NEW SYRINGE FOR USE IN ANY SMART PUMP. WE CONTINUE TO USE THE OLD DESIGN, SO THAT ALL MEDICATIONS ARE BEING DELIVERED SAFELY TO PATIENTS (VALIDATED WITH ALARIS PUMP). COVIDIEN IS HAVING DIFFICULTY DELIVERING THE OLD DESIGN NOW DUE TO LIMITED INVENTORY. WITHOUT THE NEW DESIGN BEING VALIDATED WITH CAREFUSION ALARIS PUMPS, WE WILL BE FORCED TO CHANGE BACK TO BD SYRINGES AND SWITCH ALL OF OUR PUMPS OVER TO BD SYRINGES AS WELL. BD SWITCH BECOMES COMPLICATED SINCE SALINE FLUSHES FROM BD ARE IN SHORT SUPPLY. WITH A NEONATAL AND PEDIATRIC POPULATION WITHIN OUR INSTITUTION, AN ADDITIONAL SAFETY RISK ARISES. CAREGIVERS WILL BE FORCED TO SELECT THE SYRINGE TYPE, I.E. COVIDIEN OR BD WITHIN ALARIS FOR SALINE FLUSHES (IF BD UNAVAILABLE WE WOULD HAVE TO USE COVIDIEN SALINE FLUSHES OR MANUFACTURE SALINE FLUSHES WHICH IS NOT IDEAL). ONE MUST WONDER NOW IF BD SYRINGES WILL BE BACK ON NATIONAL BACK ORDER. DO INSTITUTIONS EVEN KNOW THAT THE REDESIGNED COVIDIEN SYRINGE HAVE NOT BEEN VALIDATED WITH THEIR SMART PUMP? JUST A NOTE, BD PURCHASING CAREFUSION. REASON FOR NOT VALIDATING THE REDESIGNED SYRINGE OF COVIDIEN? (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
91534 CAREFUSION ALARIS PUMPS INFUSION PUMP FRN CAREFUSION
91535 COVIDIEN SYRINGE SYRINGE FMF COVIDIEN

Patients

Seq Age Sex Outcome Treatment
1