BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 2885092 · Received December 12, 2012

    Report

    Report Number
    9616066-2012-00892
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE SET WAS IN USE ON AN ICU VENTILATOR PT, AND BLOOD LEAKED OUT ONTO THE BED SHEET THROUGH A CRACK IN THE CAP. SHE REPORTED THAT THE BLEED LASTED ABOUT 20 MINUTES BEFORE IT WAS NOTICED. AFTER THE EVENT THE PT HAD A 2 GRAM DROP IN HEMOGLOBIN; ACTUAL LABORATORY RESULTS NOT PROVIDED BUT THE PT REMAINED STABLE AND DID NOT REQUIRE BLOOD REPLACEMENT. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXTENSION SET FPA CAREFUSION CORPORATION 20043E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULE ADMINISTRATION SET:| MODEL/LOT UNK