BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

    MDR report key: 4932358 · Received July 22, 2015

    Report

    Report Number
    8041145-2015-00058
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    August 14, 2014
    Report Date
    July 22, 2015
    Manufacturer
    NIPRO THAILAND CORPORATION LTD
    Product Code
    FJK
    PMA / PMN Number
    K072024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INVESTIGATION RESULT ATTACHED.

    Description of Event or Problem · 1

    AFTER 2 HOURS OF INITIATION OF DIALYSIS TREATMENT, NURSE PERFORMED HOURLY CHECKING OF BLOODLINES, EVERYTHING WAS OK, 15 MINUTES LATER THE NURSE HEARD A "SUCKING" SOUND AROUND THE PATIENT AND OBSERVED A KINKING IN THE ARTERIAL LINE JUST BEFORE ENTERING THE ARTERIAL CHAMBER, TREATMENT IS IMMEDIATELY STOPPED. LINES ARE REMOVED FOR FURTHER ANALYSIS, THE PATIENT COMPLAINS OF ABDOMINAL PAIN, BLOOD IS DRAWN FROM THE PATIENT AND HEMOLYSIS WAS CONFIRMED. AS THE PATIENT IS STABLE, THE TREATMENT WAS RESTARTED IN THE SAME MACHINE WITH NEW BLOOD LINES FROM THE SAME LOT. PATIENT CONTINUED TO COMPLAIN OF ABDOMINAL PAIN, PATIENT IS SENT TO THE HOSPITAL. REACTIVE PANCREATITIS. PATIENT WAS DISCHARGED 6 DAYS AFTER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476562 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET BLOOD TUBING SET FJK NIPRO THAILAND CORPORATION LTD A252R/V777R 14B11

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization