BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 4914797 · Received July 13, 2015

    Report

    Report Number
    8010762-2015-00806
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 24, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT REQUESTED TO RETURN FOR MANUFACTURERS LABORATORY INVESTIGATION AS THE FAILURE IS KNOWN AND IS THOROUGHLY INVESTIGATED UNDER (B)(4). THE INVESTIGATION UNDER (B)(4) IDENTIFIED THAT THE FAILURE IS CAUSED BY TOLERANCE INTERFERENCE IN CURRENT DESIGN. MAQUET CARDIOPULMONARY WILL IMPLEMENT CORRESPONDING ACTION STEPS REGARDING THE DESIGN AND TOLERANCE CRITERIA'S OF THE DIALYSIS PORT. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS COMPLAINT WILL BE CLOSED. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    TRANSLATION FROM THE ORIGINAL INCIDENT REPORT IN (B)(6): "DURING PATIENT TREATMENT FLUID LEAKING FROM DIALYSIS LOCK / VALVE. NO SIGNIFICANT BLOOD LOSS, PERFUSION WAS COMPLETED WITHOUT ANY FURTHER ISSUES." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451766 HLM TUBING SET W/SOFTLINE COATING DWF DWF MAQUET CARDIOPULMONARY AG HQV 10803 92162289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other