BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 8766943 · Received July 8, 2019

    Report

    Report Number
    3010017366-2019-00002
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 21, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY DID NOT REQUEST THE PRODUCT BACK FOR INVESTIGATION SINCE MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCT, SHOWING A SIMILAR MALFUNCTION, HAS BEEN INVESTIGATED IN #703007205: WHEN PRIMING WITH WATER, A LEAK WAS DETECTED AT THE POINT CLAIMED BY THE CUSTOMER (POS 5.) 'OPENING FOR HOLDER'. BASED ON THIS, THE FAILURE COULD BE CONFIRMED. TREND SEARCH: TREND SEARCH WERE PERFORMED.. (B)(4). RISK ASSESSMENT AND CONTROL: QUADROX-I SMALL ADULT/ADULT, QUADROX-ID ADULT DMS #1464420 VERSION13 THE RISK IS COVERED. H1.2.6; H2.8.3; H2.8.4; H2.9.20; H2.9.21; H2.9.22; H2.9.23; H2.9.24; H2.9.25. THE MOST PROBABLE ROOT CAUSE OF THE FAILURE IS UNKNOWN. 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

    COMPLAINT: # (B)(4).

    Description of Event or Problem · 1

    DURING PRIMING LEAK WAS DETECTED AT OPENING FOR HOLDER OF QUADROX-I ADULT HMO 70000+VHK 71000. OXYGENATOR WAS REPLACED AS CORRECTIVE ACTION. COMPLAINT NO:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560720 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 92261425

    Patients

    Seq Age Sex Outcome Treatment
    1