BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 5526427 · Received March 25, 2016

    Report

    Report Number
    8010762-2016-00219
    Event Type
    Malfunction
    Date Received
    March 25, 2016
    Report Date
    March 7, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE CIRCUIT WAS DISCARDED AT THE HOSPITAL; THEREFORE A MANUFACTURER LABORATORY INVESTIGATION OF THE PRODUCT IS NOT POSSIBLE. A REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED. NO SIMILAR INCIDENT WAS FOUND FOR CLOTTING ON THE CENTRIFUGAL PUMP IN HLS SET. A DHR REVIEW OF THE PRODUCT IN QUESTION IS NOT POSSIBLE AS THE CIRCUIT WAS DISCARDED AND THEREFORE THE CENTRIFUGAL PUMP DETAILS ARE NOT AVAILABLE. CLOTTING IS A KNOWN PHENOMENON. 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 HLS SET IN QUESTION 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. 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 CENTRIFUGAL PUMP WHICH IS REGISTERED UNDER 510(K): K102726.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISPOSED OF BY THE FACILITY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. THE CONCERNED COMPONENT IS THE ROTAFLOW CENTRIFUGAL PUMP. 510(K): K080470.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLOW PERFORMANCE WAS INCONSISTENT (PRESSURES AND FLOWS). IT WAS DETERMINED THAT A CIRCUIT CHANGE WAS REQUIRED. UPON CIRCUIT CHANGE, CLOT WAS OBSERVED IN THE CENTRIFUGAL CONE POSSIBLY HEMOLYZING THE PATIENT BLOOD. CIRCUIT WAS NOT RETAINED. THE SET WAS REPLACED DURING TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182086 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1