BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5701657 · Received June 6, 2016

    Report

    Report Number
    8010762-2016-00368
    Event Type
    Malfunction
    Date Received
    June 6, 2016
    Date of Event
    May 18, 2016
    Report Date
    May 18, 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

    Narratives

    Additional Manufacturer Narrative · 1

    FOR FURTHER INVESTIGATION A DEVICE HISTORY RECORD OF THE COMPLAINED PRODUCT 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. 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

    (B)(4). PRODUCT WAS RECEIVED FOR EVALUATION UNDER COMPLAINT # (B)(4). DURING THIS INVESTIGATION IN ADDITION IT WAS FOUND THAT A CRACK ON UPPER LUER LOCK ON ARTERIAL SIDE OF 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. INVESTIGATION IS STILL PENDING. 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 ADULT WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING INVESTIGATION OF COMPLAINT (B)(4), AN ADDITIONAL MALFUNCTION (A CRACK ON UPPER LUER LOCK ON THE ARTERIAL SIDE) WAS FOUND. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356722 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92144502

    Patients

    Seq Age Sex Outcome Treatment
    1