BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 8487185 · Received April 5, 2019

    Report

    Report Number
    8010762-2019-00095
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 12, 2019
    Report Date
    July 31, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH WAS REQUESTED THE PRODUCT BACK FOR INVESTIGATION IN THE LABORATORY OF MANUFACTURER. TIGHTNESS TEST WAS PERFORMED AGAIN. A LEAK ON THE DIALYSIS LOCK & VALVE WAS DETECTED. BASED ON THIS, THE REPORTED FAILURE COULD BE CONFIRMED. THE DHR FOR COMPLAINT 703007280 AND LOT 70126516 HAS BEEN REVIEWED ON 2019-07-30 (DMS#2630385 ). 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 (DMS#(B)(4)) AND THE MOST POSSIBLE ROOT CAUSE IS ASSOCIATED TO WRONG DESIGN: INAPPROPRIATE MATERIAL. MAQUET CARDIOPULMONARY GMBH HAS BEEN ALREADY INITIATED A CAPA 17-07-003. AS A PREVENTIVE ACTION TO ENSURE A DESIGN CHANGE IS INTENDED TO IMPROVE THE SEALING PROPERTIES OF THE DIALYSIS-VALVE. ECR #18090501 HAS BEEN INITIATED REGARDING TO THIS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). REFERENCE EXEMPTION # E2018002.

    Description of Event or Problem · 0

    REF.: #(B)(4), CUSTOMER REF. :#(B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL: "WHEN MONITORING THE CARDIOTOMY OF THE ECC PROCEDURE, BLOOD DROPS WERE OBSERVED COMING OUT AT THE SHUTTER CAP POST LOCK. NO CONSEQUENCE ON THE ECC PROCEDURE. NUMBER OF THE QUADROX MEMBRANE SET REF HQV13122 LOT #92260007 PROBLEM AT THE MANUFACTURING LEVEL?" (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282494 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HQV 13122 92260007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention