BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK SYRINGES

    MDR report key: 3010954 · Received March 15, 2013

    Report

    Report Number
    2243072-2013-00005
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    December 16, 2012
    Report Date
    March 15, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED. THIS IS 3 OF 5 RELATED INCIDENTS FOLLOWING REPORT NUMBERS: 2243072-2013-00003, 2243072-2013-00004, 2243072-2013-00006, 2243072-2013-00007.

    Description of Event or Problem · 1

    PT ON AN INFUSION OF NOR ADRENALINE 8MGS/40ML INFUSING AT 30MLS/HOUR, SYRINGE CHANGED AT 01.45 AND AT 03.00 BRAUN PERFUSER PUMP ALARMED HIGH PRESSURE. CENTRAL ACCESS DID NOT APPEAR TO BE BLOCKED - OTHER INFUSIONS RUNNING THOUGH IT. ANOTHER INFUSION OF NOR ADRENALINE WAS MADE UP AND STARTED THROUGH ANOTHER BRAUN PERFUSER PUMP WITH NO HIGH PRESSURE NOTED. PT'S BLOOD PRESSURE DID DROP AT THIS TIME, MEDICAL STAFF IN ATTENDANCE AND ADRENALINE INFUSION INCREASED AT THIS TIME TO COMPENSATE FOR SHORT PERIOD OF TIME WHEN NOR ADRENALINE NOT INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110460 BD PLASTIPAK SYRINGES HYPODERMIC SYRINGE FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1