BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON PUMP I.V. SET

    MDR report key: 1023725 · Received March 27, 2008

    Report

    Report Number
    9614279-2008-00009
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 20, 2008
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K904518
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE SET CONSISTED OF THE UNIVERSAL CHAMBER ASSEMBLY DOWN TO THE TUBING SEGMENT OF THE MIDDLE Y-CONNECTOR ASSEMBLY. THE Y-CONNECTOR ASSEMBLY AND THE REMAINDER OF THE SET WERE DISCONNECTED FROM THE TUBING AND WERE NOT RETURNED FOR EVALUATION. THE O.D. OF THE TUBING WAS MEASURED PER THE APPLICABLE DESIGN SPECIFICATION AND FOUND TO BE WITHIN SPECIFICATION. TRACES OF SOLVENT ON THE TUBING INDICATED THAT THE TUBING WAS INSERTED ALL THE WAY INTO THE FEMALE LUER Y-CONNECTOR ADAPTER. VISUAL INSPECTION INDICATES THAT THE AMOUNT OF SOLVENT APPLIED MAY HAVE BEEN SUFFICIENT. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY. CUSTOMER RECEIVING FLUIDS VIA GRAVITY THROUGH THE IV SET, A TECH NOTICED THE PT'S BLOOD WAS BACKING UP INTO THE LINE, THE NURSE WENT TO GET THE NECESSARY ITEMS FOR FLUSHING THE IV LINE, WHEN THE NURSE RETURNED NOTICED THAT THE TUBING RIGHT ABOVE THE DISTAL INJECTION PORT COMPLETELY CAME APART FROM THE PORT. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THAT WHEN THE NURSE CAME BACK IN THE ROOM TO FLUSH THE LINE, THE TUBING HAD COME APART AND BLOOD WAS LEAKING FROM THE PT ONTO THE FLOOR. BLOOD LOSS COULD NOT BE ESTIMATED, HOWEVER, BLOOD REPLACEMENT WAS NOT NECESSARY. THE PT SUFFERED NO ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THIS INCIDENT. THE LOT NUMBER REMAINS UNK AND THE FACILITY COULD NOT MAKE A DETERMINATION AS TO THE LOT NUMBER FROM THEIR INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON PUMP I.V. SET PUMP I.V. SET FPA B. BRAUN OF DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other