BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 8726529 · Received June 24, 2019

    Report

    Report Number
    8010762-2019-00185
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 10, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCT, SHOWING A SIMILAR MALFUNCTION, HAS BEEN INVESTIGATED IN #(B)(4): WHEN PRIMING WITH WATER, A LEAK WAS DETECTED AT THE POINT CLAIMED BY THE CUSTOMER (POS5.) 'OPENING FOR HOLDER'. FAILURE COULD BE CONFIRMED. FURTHER INVESTIGATION OF THE SAMPLE IS NOT POSSIBLE AT THIS MOMENT DUE TO SAFETY REASONS IN LABORATORY. THEREFORE, EXACT CAUSE OF THE FAILURE COULD NOT BE IDENTIFIED. DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMALITY WAS FOUND. TREND SEARCH WAS PERFORMED. 8 ADDITIONAL COMPLAINTS WERE RECORDED IN LAST 12 MONTHS. BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED AND NO SYSTEMIC ISSUE COULD BE DETERMINED. 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. IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6).

    Description of Event or Problem · 0

    COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DETECTED LEAKING AT OPENING FOR HOLDER OF QUADROX-I ADULT HMO 70000 +VHK71000 (REF NO: VKMO 70000) DURING BYPASS SURGERY. ACTION: REPLACE THE OXYGENATOR COMPLAINT: # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520030 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH VKMO 70000 92260034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention