BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 2983624 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04981
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED NOR A ROOT CAUSE IDENTIFIED FOR THE REPORTED PROBLEM OF LEAK - BLOOD LEAK. THERE WERE NO SAMPLES AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS UNKNOWN, SO NO BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BLOOD LEAK DURING HEMODIALYSIS THERAPY, THE LEAK WAS OBSERVED FROM THE CONNECTION OF THE STREAM STERILIZED BLOODLINE WITH ARTERIAL CHAMBER AND THE DIALYZER. IT WAS NOTICED IMMEDIATELY. AS SOON AS THE BLOOD ENTERED THE DIALYZER THE PATIENT REALIZED THE PROBLEM AND DID NOT LOSE ANY BLOOD. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT MEDICAL INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86579 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD*

    Patients

    Seq Age Sex Outcome Treatment
    1 BLOODLINES