BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK SYRINGES

    MDR report key: 3010955 · Received March 15, 2013

    Report

    Report Number
    2243072-2013-00006
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    January 29, 2013
    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 4 OF 5 RELATED INCIDENTS FOLLOWING REPORT NUMBERS: 2243072-2013-00003, 2243072-2013-00004, 2243072-2013-00005, 2243072-2013-00007.

    Description of Event or Problem · 1

    NOR ADRENALINE INFUSION INFUSING AT 50MLS/HR. BRAUN PUMP ALARMED PRESSURE. NO OBVIOUS OCCLUSION EVIDENT. PUMP RECOMMENCED AND THE SAME OCCURRED. ANOTHER SYRINGE DRIVER WITH NOR ADRENALINE WAS COMMENCED AND THE LUMEN OF THE CENTRAL LINE WHERE THE INITIAL NOR ADRENALINE WAS INFUSING WAS FLUSHED WITH NO PROBLEM. THE SAME THING HAPPENED AGAIN AND THE PRESSURE FUNCTION WAS INCREASED FROM 5 TO 9. THE PUMP ALARMED AGAIN. THE NOR ADRENALINE WAS THEN TRANSFERRED ONTO THE FEMORAL DOUBLE LUMEN CATHETER WHICH WAS INSERTED FOR CVVHF BUT HAD NOT BEEN COMMENCED AT THIS POINT - THE NOR ADRENALINE THEN SEEMED TO INFUSE. THE LUMEN ON THE CENTRAL LINE WAS FLUSHED AND WAS PATENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110301 BD PLASTIPAK SYRINGES HYPODERMIC SYRINGE FMF BECTON DICKINSON 1211214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention