BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOODLINE FOR HEMODIALYSIS

    MDR report key: 2091908 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06107
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 2, 2011
    Manufacturer
    NIKKISO MEDICAL SYSTEMS GMBH
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT IN THE ARTERIAL TUBING THEY OBSERVED SOMETHING WHITE AND THE LUMEN WAS LESS THAN NORMAL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOODLINE FOR HEMODIALYSIS SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK NIKKISO MEDICAL SYSTEMS GMBH 091224

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE