BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS HARDSHELL CARDIOTOMY RESERVOIR

    MDR report key: 5946466 · Received September 13, 2016

    Report

    Report Number
    8010762-2016-00561
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 31, 2016
    Report Date
    August 31, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510(K): K102919.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE RESERVOIR SHOWS CLOTTING ACCORDING TO THE PICTURE SENT ALONG WITH THE COMPLAINT. CLOTTING COULD BE CONFIRMED. CLOTTING IS A KNOWN PHENOMENON TO MAQUET CARDIOPULMONARY AND HAS BEEN THOROUGHLY INVESTIGATED IN A PREVIOUS COMPLAINT. THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. BASED ON THESE RESULTS AND THE INFORMATION AVAILABLE AT THIS TIME NO FURTHER INVESTIGATION WILL BE PERFORMED. THIS DATA WILL ALSO BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "THERE WAS CLOTTING IN THE RESERVOIR DURING PATIENT USE." NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599113 VENOUS HARDSHELL CARDIOTOMY RESERVOIR FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG VKMO 10000 92178706

    Patients

    Seq Age Sex Outcome Treatment
    1