BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO SET - BLOOD TUBING LINE

    MDR report key: 940170 · Received November 5, 2007

    Report

    Report Number
    1056186-2007-00003
    Event Type
    Injury
    Date Received
    November 5, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 19, 2007
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED 3-5 MINUTES INTO TREATMENT. AIR DETECTOR ALARM OCCURRED AND DISCOVERED AIR IN LINES. DISCONNECTED PATIENT AND RECIRCULATED TO REMOVE AIR AND BLOOD PUMP SEGMENT BEGAN LEAKING BLOOD. THE TREATMENT WAS DISCONTINUED. THE PATIENT LOST APPROXIMATELY 300CC OF BLOOD AND TREATMENT WAS RESTARTED WITH NEW LINES AND NEW DIALYZER. THERE WERE NO COMPLICATIONS NOTED WITH PATIENT AFTER INCIDENT. THE RUPTURE OCCURRED APPROXIMATELY 2.5-3" ON BLOOD PUMP SEGMENT. UPON INSPECTION OF TUBING AND MACHINE ROLLER PUMP, IT WAS DISCOVERED THAT PUMP SEGMENT MAY NOT BE SEATED INCORRECTLY AND IF TOO FAR FORWARD CAN RUB ON PART OF PUMP AND CREATE DAMAGE TO LINE THAT EVENTUALLY CAUSES RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO SET - BLOOD TUBING LINE BLOOD TUBING LINE FJK NIPRO MEDICAL CORPORATION A217/V806 06F20

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening