BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 5990975 · Received September 30, 2016

    Report

    Report Number
    8010762-2016-00600
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    January 28, 2016
    Report Date
    September 9, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS DISCARDED BY THE HOSPITAL; THEREFORE NO MANUFACTURER LABORATORY INVESTIGATION WAS POSSIBLE. SEVERAL ATTEMPTS WERE PERFORMED TO OBTAIN THE OXYGENATORS SERIAL NUMBER FOR A DHR REVIEW, THOSE ATTEMPTS WERE NOT SUCCESSFUL, THEREFORE A DHR REVIEW OF THE PRODUCT IN QUESTION WAS NOT POSSIBLE. A REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED. THE INVESTIGATION RESULTS OUT OF A SIMILAR COMPLAINT WERE AS FOLLOWS: THE PRODUCT WAS TESTED AND WAS OPERATING WITHIN THE MANUFACTURER'S SPECIFICATIONS. NO CLOTTING WAS OBSERVED. A DHR REVIEW WAS PERFORMED, NO ABNORMALITIES WERE DETECTED. A SAP TREND SEARCH WAS PERFORMED FOR HMOD 70000, FAILURE CODE: CLOTTING, WITH THE FOLLOWING OUTCOME: 11 COMPLAINTS WERE FOUND SINCE 10/2011. ALL OF THEM ARE CLOSED. DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. CLOTTING IS A KNOWN PHENOMENON AND HAS BEEN 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, THE OXYGENATOR IN OPERATED WITHIN MAQUET CARDIOPULMONARY SPECIFICATIONS. THIS DATA WILL 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.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: I WAS MADE AWARE OF THIS EVENT ON(B)(6) 2016. THE CUSTOMER STATED THAT DURING (B)(6) 2016 A PATIENT PLACED ON SUPPORT USING A BEQ-HMOD70000 REQUIRED FOUR CHANGE-OUTS TO NEW OXYGENATORS IN THE COURSE OF SUPPORT. THE CUSTOMER STATED THAT THE PATIENT REQUIRED A HEPARIN DOSING OF 6000 IU/HR MAINTAINING ACTS OF 192-208 SECS. THE CUSTOMER STATED THAT OF THE FOUR OXYGENATORS USED, ONE HMOD70000 CLOTTED WITHIN 12 HRS OF PLACEMENT WITH NO DECREASE IN GAS TRANSFER OR PERFORMANCE. NO ADVERSE EFFECTS WERE REPORTED WITH RESPECT TO THE PATIENT. THE PRODUCT WAS NOT RETAINED FOR INSPECTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641207 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000

    Patients

    Seq Age Sex Outcome Treatment
    1 36