BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO AVF SET

    MDR report key: 119196 · Received September 11, 1997

    Report

    Report Number
    1118880-1997-00222
    Event Type
    Malfunction
    Date Received
    September 11, 1997
    Date of Event
    August 11, 1997
    Report Date
    August 12, 1997
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SPLIT WAS FOUND IN THE PVC TUBING ABOUT 1/16 OF AN INCH BELOW THE CONNECTOR OF THE ARTERIAL-VENOUS FISTULA NEEDLE SET. WHEN THE TUBING BECAME PRESSURIZED AT THE INITIATION OF DIALYSIS, LEAKAGE OCCURRED THROUGH THE SPLIT. THE ATTENDING HEALTHCARE PROVIDER STOPPED THE PUMP, CLAMPED AND CUT THE TUBING OFF BELOW THE SPLIT SECTION. A NEW CONNECTION WAS ATTACHED AND DIALYSIS WAS COMPLETED WITHOUT FURTHER INCIDENT. THE REPORTER BLOOD LOSS WAS DESCRIBED AS MINIMAL, AND THE PATIENT IS REPORTED TO "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTUAL NEEDLE SET FIE TERUMO MEDICAL CORP. NA VH1551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN