BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2221264 · Received August 17, 2011

    Report

    Report Number
    9616066-2011-00469
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. (B)(4). AN INVESTIGATION COULD NOT BE PERFORMED. THE REPORTER INDICATED THAT THE SET WAS DISCARDED. THE CAUSE OF REPORTED LEAK IS UNK.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT IN THE OPERATING ROOM WAS ON A NITROGLYCERIN DRIP AT 9ML/HR (15MCG/HR) BUT THE USER COULD NOT GET THE PT'S BLOOD PRESSURE UNDER CONTROL. IT WAS SUBSEQUENTLY DISCOVERED THAT THE SET WAS LEAKING INSIDE THE PUMP AND A HOLE WAS FOUND IN THE PUMPING SEGMENT NEAR THE UPPER FITMENT. THE TUBING WAS CHANGED AND THE NITRO WAS RESTARTED. THE PT'S BLOOD PRESSURE STABILIZED. THE SET WAS DISCARDED. THE CUSTOMER STATES THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORP. 2408-0500 UNK

    Patients

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