BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0109 ACCURA SYSTEM DISP SET

    MDR report key: 1984339 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01758
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    July 30, 2010
    Report Date
    August 4, 2010
    Manufacturer
    HAEMOTRONIC
    Product Code
    KDI
    PMA / PMN Number
    K021615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. THE COMPLAINT WAS CONFIRMED THAT THERE WAS A BREAK AT THE TOP OF THE ROSEBOX. THE SUPPLIER'S INVESTIGATION REPORT INDICATES THAT THE FILTER IS PURCHASED FROM A QUALITY SUPPLIER. THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A SUPPLIER CORRECTIVE ACTION REPORT WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO BAXTER (B)(4) THAT THE ROSEBOX FILTER IN THE DRIP CHAMBER WAS LEAKING DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0109 ACCURA SYSTEM DISP SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI HAEMOTRONIC B082119

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE