BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 10764757 · Received October 30, 2020

    Report

    Report Number
    2242352-2020-00942
    Event Type
    Death
    Date Received
    October 30, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 30, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    MWS
    UDI-DI
    00607567700581
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. THE LOT # 25149424 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I STABILIZER, CUSTOMER REPORTS PATIENT DEATH IN OPERATING ROOM AFTER AVR / CABG PROCEDURE. CUSTOMER REPORTS THAT PATIENT WAS UNSTABLE DURING PROCEDURE AND THEY COULD NOT CLOSE THE CHEST. CUSTOMER STATES THAT OM-10000 WAS NOT A CAUSE. NO FURTHER INFORMATION IS AVAILABLE. STABILIZER HAD NOTHING TO DO WITH DETERIORATION OF PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231184 ACROBAT-I STABILIZER STABILIZER, HEART MWS MAQUET CARDIOVASCULAR LLC ACROBAT-I STABILIZER 25149424 00607567700581

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention