BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE COMPOUNDER

    MDR report key: 3010737 · Received March 12, 2013

    Report

    Report Number
    MW5029384
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    B BRAUN
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR PINNACLE COMPOUNDER STARTED MAKING A VERY LOUD GRINDING SOUND. A METAL TO METAL TYPE OF NOISE. IT CAME FROM VARIOUS PORTS AT DIFFERENT TIMES. BUT DID CONTINUE WHILE PUMPING OUR TPNS. I CALLED OUR SERVICE REP (B)(4) AT BRAUN AND HE TOLD ME TO SEND THE MACHINE BACK. HE ALSO SAID THAT WE WOULD GET A NEW MACHINE THE NEXT DAY BY 10:30 WHICH WE DID. WE THEN SENT BACK THE DEFECTIVE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104463 PINNACLE COMPOUNDER TPN COMPOUNDER NEP B BRAUN VERSION F

    Patients

    Seq Age Sex Outcome Treatment
    1