BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5697308 · Received June 3, 2016

    Report

    Report Number
    8010762-2016-00364
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS RECEIVED FOR EVALUATION UNDER (B)(4). DURING THIS INVESTIGATION IN ADDITION IT WAS FOUND THAT A LEAKAGE ON LUER LOCK OF THE DE-AIRING VALVE ON THE OXYGENATOR OCCURRED. THIS ADDITIONAL COMPLAINT WAS OPENED TO EVALUATE THIS FAILURE. NO EVIDENCE WAS PROVIDED THAT THIS FAILURE WAS NOTICED WITHIN THE INITIAL COMPLAINT REPORT. THE MANUFACTURER`S REVIEW OF THE QUALITY CONTROL PROCESS INDICATED THAT A 100% FUNCTIONAL INSPECTION FOR LEAKAGE IS CONDUCTED DURING MANUFACTURING. THE INFORMATION OBTAINED SO FAR IN THIS INVESTIGATION WOULD CONFIRM THAT THE DEVICE MET ITS SPECIFICATION AT THE TIME OF MANUFACTURING AND THEREFORE ALL DAMAGES FOUND ON THE PRODUCT ARE DUE TO EXCESSIVE OR INADEQUATE EXTERNAL PHYSICAL FORCE THAT WAS EXERTED ON THE PRODUCT AFTER THE RELEASE. THE EXACT ROOT-CAUSE WHICH LED TO THE DESCRIBED FAILURE COULD NOT BE IDENTIFIED 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-I PEDIATRIC WHICH IS REGISTERED UNDER 510(K): K132829.

    Additional Manufacturer Narrative · 1

    FOR FURTHER INVESTIGATION THE DEVICE HISTORY RECORD WAS REVIEWED BY A QUALITY ENGINEER. THE (B)(4) FOR LOT 70103942 FROM (B)(4) WAS REVIEWED. THE PRODUCT PASSED EVERY PRODUCTION STEP AND WAS NOT MARKED AS SCRAP. THERE WERE NO REFERENCES FOUND, WHICH WOULD INDICATE A NONCONFORMANCE 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

    DURING INVESTIGATION OF (B)(4), AN ADDITIONAL MALFUNCTION (LEAKAGE ON LUER LOCK OF THE DE-AIRING VALVE ON THE OXYGENATOR) WAS FOUND. (B)(4).

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353892 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 31000 92164546

    Patients

    Seq Age Sex Outcome Treatment
    1