BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER PUMP

    MDR report key: 10020183 · Received May 4, 2020

    Report

    Report Number
    10020183
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    July 7, 2019
    Report Date
    April 22, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PLACED HEPARIN GTT ON BAXTER PUMP AND FEW MOMENTS LATER GOT AN "IMPROPER SHUTDOWN" MESSAGE ON SCREEN. ATTEMPTED 3 TIMES TO CORRECT, BUT INSTEAD OF WASTING MORE TIME (THE PATIENT WAS A ST-ELEVATION MYOCARDIAL INFARCTION [STEMI] GOING TO CATH LAB), ACT CHOSE TO PROCEED TO HELICOPTER AND TROUBLESHOOT DURING FLIGHT. WHILE ENROUTE, FLIGHT REGISTERED NURSE (FRN) ATTEMPTED ONE MORE TIME (TO SEE THE ISSUE FIRST HAND) TO LOAD THE PUMP AND GOT THE SAME MESSAGE. FRN GOT A SECOND BAXTER PUMP (SAME TUBING) AND GOT A "CLOSE DOOR" ALARM AND AFTER SEVERAL ATTEMPTS TO LOAD AND RELOAD TUBING, A THIRD PUMP WAS RETRIEVED. WE LANDED WHILE PRIMING BRAUN EXTENSION SET TO PUMP TUBING, FRN ATTEMPTED TO PROGRAM BRAUN PUMP WHILE ENROUTE TO CATH LAB. GOT PATIENT TO CATH LAB BEFORE PUMP WAS READY. CATH LAB TEAM MADE AWARE THAT PT WAS ON HEPARIN BUT DURING FLIGHT, ACT EXPERIENCED ISSUES WITH THE PUMP, SO THE HEPARIN WAS STOPPED. TWO BAXTER MEDICATION. BOTH PUMPS WERE REMOVED FROM SERVICE AND BIOMED WAS NOTIFIED. BIOMED SENT DEVICES TO BAXTER FOR THEIR INVESTIGATION. BIOMED RECEIVED PUMP BACK FROM BAXTER, BAXTER REPORTED: DEVICES WAS EVALUATED AND TESTED, AND CUSTOMER REPORTED ALLEGATION COULD NOT BE CONFIRMED OR REPRODUCED. NO FAULT FOUND ON THE DEVICES. DEVICES HAVE BEEN RELEASED FOR CUSTOMER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485422 BAXTER PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA