BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5843944 · Received August 3, 2016

    Report

    Report Number
    8010762-2016-00501
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MAQUET (B)(4). MAQUET (B)(4) DID NOT REQUEST THE PRODUCT FOR INVESTIGATION AS THE FAILURE IS ALREADY KNOWN AND HAS BEEN INVESTIGATED UNDER A PREVIOUS COMPLAINT. THE INVESTIGATION RESULTS OF THIS PREVIOUS COMPLAINT ARE AS FOLLOWS: NO CLOTS OR OTHER ABNORMALITIES WERE FOUND DURING VISUAL INSPECTION OF THE PRODUCT IN THE LABORATORY OF THE INCOMING INSPECTION. A DHR REVIEW HAS BEEN PERFORMED, NO ABNORMALITIES WERE FOUND, THE OXYGENATOR IN QUESTION WAS COATED WITH A SOFTLINE LAYER AND THE COATING CONCENTRATION MET THE PROCESS SPECIFICATIONS. FURTHERMORE THE OXYGENATOR WAS TESTED IN THE QA LABORATORY FOR IT'S PRESSURE DROP PERFORMANCE WITH THE FOLLOWING OUTCOME: THE OXYGENATOR WAS FIRSTLY CLEANED AND DISINFECTED WITH NATRIUM HYPOCHLORITE AND DISIFIN. AFTER THAT THE OXYGENATOR WAS TESTED FOR ITS PRESSURE DROP PERFORMANCE. A PRESSURE DROP WHICH WAS NOT ACCORDING TO OUR SPECIFICATIONS COULD BE OBSERVED DURING TESTING. AS A MATTER OF FACT THE INTEGRITY OF THE SOFTLINE COATING IS NOT GUARANTEED AFTER THE DISINFECTION PROCESS WHICH INVOLVES A VERY AGGRESSIVE SOLUTION, THEREFORE THE PROBABILITY OF MICRO CLOTTING INSIDE THE OXYGENATOR RAPIDLY INCREASES, AND CONSEQUENTLY HIGH PRESSURE DROP COULD BE OBSERVED IN THIS CASE. BASED ON THESE RESULTS AND THE INFORMATION AVAILABLE AT THIS TIME NON DEVICE RELATED FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIO-PULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION 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 QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: "DURING ECC THE PRESSURE RAISES MASSIVELY WITH ALL CONCOMITANTS AND THE QUADROX NEEDED TO BE EXCHANGED. THIS OCCURRED ABOUT HALF AN HOUR AFTER STARTING ECC THE DELTA P RAISES DRAMATICALLY TO A MAXIMUM OF 350MMHG. NO CONSEQUENCES FOR THE PATIENT." (B)(4).

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497418 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HQV 1509-1 92164429

    Patients

    Seq Age Sex Outcome Treatment
    1