BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8030665-2000-00247

    MDR report key: 291242 · Received August 18, 2000

    Report

    Report Number
    8030665-2000-00247
    Event Type
    Injury
    Date Received
    August 18, 2000
    Date of Event
    July 18, 2000
    Report Date
    August 18, 2000
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTS THAT 90 MINUTES INTO TREATMENT THE 4TH USE ARTERIAL LINE WAS FOUND KINKED. THE ROLLER CAMPS WERE FOUND TO NOT BE FULLY TIGHTENED AND THE LINE ROLLED-UP INTO THE HOUSING. THE CLAMPS WERE TIGHT AT THE INITIATION OF THE TREATMENT. HEMOLYSIS WAS CONFIRMED BUT PT REMAINED ASYMPTOMATIC. USER FACILITY REPORT TO BE FILED ON MACHINE AND LINE. PT WAS DISCHARGED FROM THE UNIT WITHOUT INTERVENTION. SAMPLE WAS SAVED FOR EXAMINATION. MEDWATCH FILED ON POTENTIAL KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FJK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other