BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SETS

    MDR report key: 9346550 · Received November 20, 2019

    Report

    Report Number
    8010762-2019-00367
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 10, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTM
    PMA / PMN Number
    K001787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH REQUESTED THE PRODUCT BACK FOR INVESTIGATION ON 2019-11-18. INFORMATION WAS RECEIVED ON 2019-12-06 THAT THE PRODUCT WAS SCRAPPED BY CUSTOMER. THEREFORE NO TECHNICAL INVESTIGATION COULD BE PERFORMED ON ACTUAL PRODUCT. A VIDEO WAS RECEIVED REGARDING FAILURE. IN THIS VIDEO, IT COULD BE SEEN THAT THE PRIMING SOLUTION IS LEAKING FROM THE HOUSING OF THE FILTER. MAQUET CARDIOPULMONARY GMBH IS AWARE OF SIMILAR COMPLAINT FROM THIS PRODUCT. SIMILAR PRODUCT, SHOWING A SIMILAR MALFUNCTION HAS BEEN INVESTIGATED IN: #703007087: 70000.0175/ 00175#QUART, HALBFERTIGTEIL WAS SENT BACK. THE PRODUCT WAS TESTED WITH AIR (APPROX. 0,1 BAR PRESSURE) UNDER WATER TO DETECT THE LEAKAGES. LEAKAGE WAS DETECTED AT THE BONDING BETWEEN THE HOUSING AND THE COVER. BASED ON THE INFORMATION ABOVE, FAILURE COULD BE CONFIRMED. SINCE ACTUAL DEFECTIVE DEVICE IS NOT AVAILABLE FOR INVESTIGATION, THE CAUSE OF THE FAILURE COULD NOT BE IDENTIFIED. THE CAUSE OF THE FAILURE IS UNKNOWN. A TREND SEARCH WAS PERFORMED FOR COMPONENT QUART, FAILURE LEAKAGE AND 5 ADDITIONAL COMPLAINTS WERE RECORDED WITHIN THE LAST 12 MONTHS. (B)(4). IN ADDITION, DEVICE HISTORY RECORDS FOR COMPLAINT (B)(4) AND LOTS 70129137 & 92271362 HAVE BEEN REVIEWED. THERE ARE NO EVIDENCES INDICATING A NON CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING THE MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. THE REPORTED FAILURE WAS IDENTIFIED AS PART OF THE CURRENT RISK MANAGEMENT FILE ((B)(4)). MITIGATIONS FOR THIS SPECIFIC FAILURE ARE IN PLACE AS PER INSTRUCTION FOR USE, DESIGN SPECIFICATIONS AND IN-PROCESS CONTROLS IN ORDER TO REDUCE OF SIMILAR FAILURES DURING THE MANUFACTURING PROCESS. THIS COMPLAINT IS BEING MONITORED AS PART OF THE COMPLAINT DATA TRENDING OF MAQUET CARDIOPULMONARY GMBH AND FURTHER INVESTIGATIONS AND MEASURES WILL BE CONDUCTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    "DURING CARDIOPULMONARY BYPASS SURGERY LEAKAGE FROM ARTERIAL FILTER QUART LOT # 70129137, WHICH IS A PART OF TUBING SET H 16105 WAS DETECTED." COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141594 TUBING SETS FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY GMBH H 16105 92271362

    Patients

    Seq Age Sex Outcome Treatment
    1