BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5545256 · Received April 4, 2016

    Report

    Report Number
    8010762-2016-00235
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 10, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE PRODUCT BACK FOR INVESTIGATION. THE DEVICE HISTORY RECORD OF THE LOT HAS BEEN INVESTIGATED AND NO ABNORMALITY FOR THE RELATED MATERIAL WAS FOUND. MOREOVER, NO SCRAP RECORD FOR THE RELATED MATERIAL WAS FOUND. ACCORDING TO THE INVESTIGATION OF MAQUET CARDIOPULMONARY (B)(4), THE LOT 92144502 WAS A REWORK LOT. HOWEVER, THE REWORK WAS RELATED TO DAMAGED BOXES AND THE OUTER BOXES WERE CHANGED. ALTHOUGH, TOTAL SET ORDER WAS (B)(4), ONLY (B)(4) OF THEM HAVE BEEN REWORKED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A VKMO AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510(K): K082117.

    Additional Manufacturer Narrative · 1

    FOR FURTHER INVESTIGATION A DEVICE HISTORY RECORD OF THE OXYGENATOR HAS BEEN REVIEWED BY THE MANUFACTURER. THE PRODUCT PASSED EVERY PRODUCTION STEP AND WAS NOT MARKED AS SCRAP. DURING THE REVIEW OF THE DHR / AVZ NO PRODUCTION PARAMETERS COULD BE IDENTIFIED THAT WOULD INDICATE A NONCONFORMANCE DURING PRODUCTION, IN REGARDS TO THE REPORTED FAILURE. BASED ON THE INVESTIGATION RESULTS OBTAINED SO FAR THE REPORTED FAILURE COULD BE CONFIRMED. THE MOST PROBABLE CAUSE COULD BE DETERMINED THAT THE AIR HAS BEEN WITHDRAWN THROUGH THE CRACKS. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION 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 INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) RECEIVED THE PRODUCT FOR MANUFACTURER LABORATORY INVESTIGATION. DURING CLEANING OF THE PRODUCT 2 LEAKING LUER LOCKS ON BLOOD OUTLET SIDE HAVE BEEN NOTICED. A LONG CRACK IN THE MIDDLE OF THE LUER LOCK ON BLOOD OUTLET CONNECTOR HAS BEEN NOTICED. ON THE ASSOCIATED SCREW CAP ADDITIONALLY A CRACK HAS BEEN FOUND. FURTHERMORE CRACKS ON BLOOD OUTLET CAP HAVE BEEN NOTICED. ON THE MALE LUER LOCK CONNECTOR WHICH HAS BEEN MOUNTED ON THE LUER LOCK OF BLOOD OUTLET CAP, IMPRINTS OF A CLAMP HAS BEEN FOUND. TWO ADDITIONAL COMPLAINTS HAVE BEEN OPENED FOR THESE ADDITIONAL MALFUNCTIONS THAT HAVE BEEN DETECTED DURING INVESTIGATION. THE COMPLAINED OXYGENATOR HAS BEEN CONNECTED TO THE ROLLER PUMP. DURING FILLING WITH SALINE SOLUTION BOTH LUER LOCKS ON BLOOD OUTLET SIDE SHOWED A LEAKAGE. SET HAS BEEN FILLED WITH 0,9% SALINE SOLUTION AND A CIRCULATION DURING A FLOW RATE OF 7 L/MIN HAS BEEN ADJUSTED. THEREBY IT HAS BEEN DETECTED THAT THE AIR BUBBLES WERE NOT ABLE TO GET OUT THROUGH THE DE-AIRING MEMBRANE AS THERE WERE NEW AIR BUBBLES BEEN WITHDRAWN IN THE OXYGENATOR. FURTHERMORE IT HAS BEEN DETECTED THAT THE LEAKING POSITIONS PULSATED WITH THE RUN OF THE PUMP. BASED ON THE INVESTIGATION RESULTS OBTAINED SO FAR THE REPORTED FAILURE COULD BE CONFIRMED. THE MOST PROBABLE CAUSE COULD BE DETERMINED THAT THE AIR HAS BEEN WITHDRAWN THROUGH THE CRACKS. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION 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 INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    MACRO BUBBLES WERE OBSERVED IN OXYGENATOR ARTERIAL LINE EXIT DURING THE LIQUID FILLING UP AND AIR EJECTING PROCESS OF OXYGENATOR AND TUBING SET PREPARATION. THE PROBLEM COULD NOT BE SOLVED BY THE USER, AND THEY REPLACED THE PRODUCT WITH A NEW ONE. NO PROBLEM OBSERVED IN THE REPLACED PRODUCT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202050 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92144502

    Patients

    Seq Age Sex Outcome Treatment
    1