BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/ SOFTLINE COATING

    MDR report key: 4890866 · Received July 1, 2015

    Report

    Report Number
    8010762-2015-00776
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. THESE SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED AND DURING A TIGHTNESS TEST, A LEAKAGE FROM THE DE-AIRING PORT COULD BE CONFIRMED. THE MANUFACTURER DETERMINED SO FAR THAT THE DE-AIRING MEMBRANE BECOMES PERMEABLE FOR FLUIDS (PRIMING SOLUTION/ BLOOD). THE INVESTIGATED CUSTOMER COMPLAINTS SHOWED NONCONFORMING AREAS IN THE MEMBRANE BODY AS WELL AS WEAK BONDING BETWEEN THE MEMBRANE AND OXYGENATOR AS MOST PROBABLE CAUSE. DETERMINING THE ROOT CAUSE IS STILL UNDER INVESTIGATION. THEREFORE MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED A CAPA PROCESS ((B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. INVESTIGATION IS STILL PENDING. 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-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR. COMPLAINTS SHOWING A SIMILAR MALFUNCTION. THESE PRODUCTS HAVE BEEN TESTED AND DURING TIGHTNESS TEST, A LEAKAGE FROM THE DE-AIRING PORT COULD BE CONFIRMED. THEREFORE MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED A CAPA PROCESS TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. EVERY OXYGENATOR - PRODUCED BY MAQUET (B)(4) - POSSESSES A DE-AIRING PORT LOCATED AT THE BLOOD INLET SIDE OF THE DEVICE. FOR THIS PURPOSE A HYDROPHOBIC PFTE (POLY-TETRA-FLUORO-ETHYLENE) MEMBRANE, WHICH IS LAMINATED ON A POLYESTER FLEECE, IS WELDED ONTO A DE-AIRING CONNECTOR. THIS COMBINATION IS FIXED ON THE OXYGENATOR BY GLUING. DUE TO LEAKAGE OF LIQUIDS THROUGH THE DE AIRING MEMBRANE, BOTH THE NUMBER OF CUSTOMER COMPLAINTS AND THE OXYGENATOR PRODUCTION FAILURE RATE, INCREASED CONSIDERABLY DURING THE LAST YEARS, PARTICULARLY SINCE 2013. THE OVERALL DUE DATE FOR THE ROOT CAUSE ANALYSIS IS 2016-03-30. UP TO DATE INVESTIGATION ACTIONS CONTINUE, HOWEVER SOME FINDINGS ARE ALREADY AVAILABLE. EXPERIMENTS COULD DEMONSTRATE THAT ROUGH HANDLING DURING WELDING AS WELL AS BAD STORAGE OF THE DE-AIRING CONNECTORS CAN RESULT IN LEAKAGE. THE FIRST MEASURE AGAINST LEAKAGE IS ALREADY TAKEN BY MANUFACTURING STACKABLE STORAGE BOXES WITH CAVITIES FOR 150 DE-AIRING CONNECTORS IN EACH CASE. THE NEW STORAGE BOXES ARE UTILIZED SINCE 2016-02-01. SINCE THAT TIME MORE THAN (B)(4) OXYGENATORS WERE MANUFACTURED AND TESTED IN THE PRESSURE TEST UNIT REGARDING INTEGRITY. LEAKAGE OF THE DEAIRING MEMBRANE WAS FOUND IN LESS THAN 0.6 PERCENT OF THE OXYGENATORS. IN THE PRECEDING 4 WEEKS IN 2016 THE PRODUCTION FAILURE RATE DUE TO LEAKAGE OF THE DE-AIRING MEMBRANE WAS NEARLY 1.3 PERCENT. IN 2015 THE AVERAGE WAS 2.7 PERCENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN INVESTIGATED IN THE LABORATORY OF THE MFR WITH THE FOLLOWING RESULTS: DURING TESTING THE PRODUCT FOR TIGHTNESS A FLUID LEAKAGE AT THE DE-AERATION MEMBRANE OF THE OXYGENATOR WAS DETECTED. THE EVENT REPORT OF COMPLAINT # (B)(4) WAS NOT DESCRIBING THIS ISSUE. MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT AND AN INTERNAL PROCESS (B)(4) WAS INITIATED TO DETERMINE THE MOST PROBABLE 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.

    Description of Event or Problem · 1

    INVESTIGATION RESULTS OUT OF COMPLAINT (B)(4) (8010762-2015-00371). THE PRODUCT HAS BEEN INVESTIGATED IN THE LABORATORY OF THE MFR WITH THE FOLLOWING RESULTS: DURING TESTING THE PRODUCT FOR TIGHTNESS, A FLUID LEAKAGE AT THE DE-AERATION MEMBRANE OF THE OXYGENATOR WAS DETECTED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP 2 FOR THE INITIAL THAT WAS SUBMITTED JULY 2,2015 AND 1 FOLLOW-UP SUBMITTED OCT 14,2015. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429473 HLM TUBING SET W/ SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HQV 6718

    Patients

    Seq Age Sex Outcome Treatment
    1