BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PUMP

    MDR report key: 4213435 · Received October 23, 2014

    Report

    Report Number
    1641965-2014-00025
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 21, 2014
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED AS IT COULD NOT DUPLICATED. UPON RECEIPT OF THIS REPORTED DEVICE FROM THE CUSTOMER, THE DEVICE UNDERWENT A THOROUGH INVESTIGATION WHICH INCLUDED A VISUAL INSPECTION AND A VOLUMETRIC SEQUENTIAL RUN OF 111ML FOR 8 STATIONS AND CONCLUDING WITH 112ML FOR 9TH STATION FOR A TOTAL VOLUME OF 1000ML. THE RESULTS OBTAINED IN THIS EVALUATION WERE IN SPECIFICATION AT +/- 3ML PER STATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT PINNACLE COMPOUNDING PUMP HAD MALFUNCTIONED. CUSTOMER STATES "ONE PATIENT IS ALWAYS REPORTING 200 ML OF SOLUTION LEFT IN THE FINAL CONTAINER AFTER THE INFUSION HAS COMPLETED. THEY HAVE REPLACED THE PATIENT IV PUMP THREE TIMES, HOWEVER THE PATIENT STILL REPORTING THE 200 ML LEFT." THE PHARMACY TECHNICIAN STATES "NO OVERFILL ALARMS ON THE PINNACLE PUMP. THEY HAVE BEEN WEIGHING THE EMPTY FINAL CONTAINER, COMPOUNDING, AND THEN WEIGHING THE FILLED FINAL CONTAINER, SUBTRACTING THE EMPTY WEIGHT AND EACH FINAL CONTAINER IS WELL WITH IN THE +/- 5 PERCENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674627 PINNACLE PUMP COMPOUNDING PUMP MODULE FRN B. BRAUN MEDICAL, INC. 601184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention