BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3023252 · Received February 27, 2013

    Report

    Report Number
    9616066-2013-00136
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE NURSE CLINICIAN REPORTED A BACK CHECK VALVE FAILURE. DETAILS OF THE EVENT WERE REPORTED AS FOLLOWS: VANCOMYCIN SECONDARY INFUSION BAG EMPTIED WITHIN 10 - 15 MINUTES OF STARTING THE INFUSION. THERE WAS NO EVIDENCE OF A PUMP MALFUNCTION AND THE SECONDARY SET-UP WAS CONFIRMED BY A SECOND NURSE. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84962 ALARIS PUMP MODULE ADMIN SET FPA CAREFUSION CORPORATION 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS SECONDARY ADMIN SET, MODEL 11448964, LOT UN| ALARIS PC UNIT, SN UNK| THERAPY DATE: UNK| THERAPY DATE: UNK| ALARIS PUMP MODULE, SN UNK