BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3133658 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00329
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. THE DEVICE HAS BEEN REC'D BUT IT HAS NOT BEEN EVALUATED YET. A F/U REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A NURSE WENT INTO A PT ROOM AND FOUND THE TUBING LEAKING BELOW THE PUMP. THE TUBING WAS CHANGED OUT. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191086 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0500 UNKNOWN

    Patients

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