BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/SOFTLLINE COATING

    MDR report key: 4924204 · Received July 16, 2015

    Report

    Report Number
    8010762-2015-00813
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 22, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT AND AN INTERNAL PROCESS ((B)(4)) WAS INITIATED TO DETERMINE THE MOST PROBABLY ROOT-CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. THE PROCESS IS IN THE ROOT-CAUSE DEFINITION AND INVESTIGATION PHASE. THE CORRECTIVE ACTION PHASE WILL IMMEDIATELY FOLLOW THE ROOT-CAUSE INVESTIGATION. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION OF APPLICABLE INVESTIGATION. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. 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-ID WHICH IS REGISTERED UNDER 510(K): K101153.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE COMPLAINT REPORT: "ACCORDING TO THE HOSPITAL, A BLOOD LEAKAGE WAS DETECTED AT THE DE-AIRING PORT OF THE OXYGENATOR. PRODUCT WAS NOT REPLACED BECAUSE PRODUCT WORKED WELL DURING ECC WITH GOOD OXYGENATION. NO CONSEQUENCE FOR THE PATIENT. BLOOD LOSS WAS ONLY A FEW DROPS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463947 HLM TUBING SET W/SOFTLLINE COATING DTZ (OR DWE) DTZ MAQUET CARDIOPULMONARY AG HQV 69001 92149964

    Patients

    Seq Age Sex Outcome Treatment
    1 Other