BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOODLINE FOR HEMODIALYSIS

    MDR report key: 2161391 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-09018
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    HAEMOTRONIC
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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 LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED BY THE SUPPLIER, AS THE SAMPLE WAS NOT RETURNED. THE ROOT CAUSE IS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT DURING THERAPY THE A BLOOD LEAK OCCURRED IN THE TUBING. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 HAEMOTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE