BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4214041 · Received August 14, 2014

    Report

    Report Number
    9616066-2014-00830
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Report Date
    July 31, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PCA TUBING CRACKED AND LEAKED. THE TUBING WAS HUNG THE PREVIOUS DAY, THE PT WAS NOT ABLATING. NO PT HARM OR MEDICAL INTERVENTION OCCURRED .NO FURTHER PT /EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487471 ALARIS PUMP MODULE ADMINISTRATION SET IV SET FPA CAREFUSION CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SYRINGE, MODEL/LOT#'S, MFG: UNK| PCA MODULE, SN: UNK| ALARIS PC UNIT, SN: UNK