BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 4924207 · Received July 16, 2015

    Report

    Report Number
    8010762-2015-00817
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 23, 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 T RETURN FOR MANUFACTURERS LABORATORY INVESTIGATION AS THE FAILURE IS KNOWN AND IS THROUGHLY INVESTIGATED UNDER CAPA (B)(4). THE INVESTIGATION UNDER CAPA (B)(4) IDENTIFIED THAT THE FAILURE IS CAUSED BY TOLERANCE INTERFERENCES IN CURRENT DESIGN. MAQUET CARDIOPULMONARY WILL IMPLEMENT CORRESPONDING ACTION STEPS REGARDING THE DESIGN AND TOLERANCE CRITERIA 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 USE A LEAKAGE FROM THE DIALYSIS LOCK AND VALVE WAS NOTICED. PRODUCT WAS NOT REPLACED. TREATMENT WAS FINISHED WITH THE COMPLAINED PRODUCT. BLOOD LOSS WAS NOT SIGNIFICANT. NO CONSEQUENCE FOR THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463823 HLM TUBING SET W/SOFTLINE COATING DTZ (OR DWE) DWF MAQUET CARDIOPULMONARY AG HQV 10803 92162289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other