BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0109 ACCURA SYSTEM DISP SET

    MDR report key: 1965019 · Received January 20, 2011

    Report

    Report Number
    1423500-2011-00815
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    March 18, 2010
    Report Date
    December 27, 2010
    Manufacturer
    HAEMOTRONICS SPA
    Product Code
    KDI
    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 DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE SAMPLE BY BAXTER AND HAEMOTRONIC COULD NOT CONFIRM A LEAK IN THE TUBING. ACCORDING TO THE HAEMOTRONIC INVESTIGATION REPORT, THE MEMBRANE OF THE ACCESS DOME WAS PARTIALLY RAISED FROM THE BODY OF THE DOME, AND THE MALE LUER LOCK ON THE DEGASSING CHAMBER DID NOT HAVE A RING. IT WAS NOTED THAT THERE WAS SOME "CRUSHING" ON THE MALE LUER ON THE DEGASSING CHAMBER, PERHAPS FROM THE USE OF A METAL CLAMP. HOWEVER, THE SAMPLE PASSED LEAK TESTING AT BOTH BAXTER AND HAEMOTRONIC. DUE TO INSUFFICIENT INFORMATION, ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. ACCORDING TO HAEMOTRONIC'S REPORT, A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT AFTER CONNECTING TO THE MACHINE, THERE WAS A LEAK FOUND IN THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 HAEMOTRONICS SPA B091997

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE