BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PRIMARY TUBING

    MDR report key: 2935516 · Received January 4, 2013

    Report

    Report Number
    9616066-2012-00943
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 14, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SECONDARY ANTIBIOTIC YELLOW IN COLOR (BELIEVED TO BE AMPHOTERICIN), WAS FOUND BACKING UP INTO THE PRIMARY BAG. IT APPEARS THAT THE CHECKVALVE FAILED. THERE WAS NO PT HARM OR MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5546 ALARIS PRIMARY TUBING FPA CAREFUSION CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SN UNK| ALARIS PC UNIT, SN UNK