BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3165665 · Received June 3, 2013

    Report

    Report Number
    9616066-2013-00386
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BACK CHECK VALVE FAILURE DURING ATG INFUSION. THE NURSE NOTICED THE PRIMARY 500 ML BAG WAS BULGING AND SAW THE ATG SECONDARY MEDICATION INFUSING UP INTO THE PRIMARY BAG. THE ATG SECONDARY BAG WAS SETUP HIGHER THAN THE PRIMARY. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243730 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK| ALARIS SECONDARY SET: MODEL UNK, LOT UNK| ALARIS PUMP MODULE: SN UNK