BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD PUMP SET W/ 1.2 FILTER

    MDR report key: 6217869 · Received December 29, 2016

    Report

    Report Number
    MW5067005
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 27, 2016
    Report Date
    December 29, 2016
    Manufacturer
    CME
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN-HOME RN CALLED THE OFFICE BECAUSE PT'S TPN PUMP HAD BEEN INFUSING FOR 21 HOURS. NURSE STATED THE TPN BAG WAS STILL 75% FULL OF TPN, SO PT ONLY RECEIVED ABOUT 25% OF HER TOTAL TPN INFUSION. PUMP WAS NOT TURNED OFF FOR ANY TROUBLESHOOTING AND NOTHING OUT OF THE ORDINARY HAD OCCURRED WHILE PT WAS HOOKED UP. ON CALL DRIVER DELIVERED A NEW PUMP TO THE PT THE SAME NIGHT OF THE EVENT AND PICKED UP THE TPN BAG, TUBING AND PUMP FOR BIOMED TO TEST THE PUMP AND ACCESSORIES. PT'S MD WAS NOTIFIED ABOUT THE PUMP UNDER INFUSING TPN TO THE PT; NO CHARGES WERE MADE DUE TO THE UNDERINFUSION. THIS IS THE SECOND OCCURRENCE OF UNDERDELIVERY IN BODYGUARD PUMPS OVER THE LAST WEEK (FIRST OCCURRENCE WAS ON A DIFFERENT PT). BIOMED RAN LONG INFUSIONS AND PUMPS PASSED PERFORMANCE VERIFICATION WITH TUBING THAT DIDN'T HAVE A FILTER. BIOMED CONCLUDED THAT IT WAS A TUBING ISSUE. WE WERE NOT ABLE TO GET THE LOT NUMBERS OF THE TUBING SETS AS FAMILIES HAD ALREADY THROWN THE PACKAGING AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863395 BODYGUARD PUMP SET W/ 1.2 FILTER BODYGUARD TUBING SET FRN CME UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR