BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 ADAPTOR

    MDR report key: 12909654 · Received December 1, 2021

    Report

    Report Number
    2242352-2021-01002
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 10, 2021
    Report Date
    February 7, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID # (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 0

    TRACKWISE ID #: (B)(4). CORRECTED SECTION: H3 - DEVICE EVAL CODE CHANGED TO DEVICE DISCARDED. H3 OTHER TEXT : DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). TREND ANALYSIS: (4110/213/67/3221) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD DEC 2019 THROUGH NOV 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. DEVICE DISCARDED: (4115/213/3221/67) DESPITE REQUEST AND/ OR CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED; HOWEVER, THE ACTUAL DEVICE INVOLVED IN THE ADVERSE EVENT HAD BEEN ALREADY DISCARDED AND THUS IRRETRIEVABLY LOST FOR TESTING. COMMUNICATION/INTERVIEWS: (4111/213/67/3221) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. THE REPORTED DEVICE IS AN OEM DEVICE, THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE PRODUCT IS NOT RETURNING. A LOT NUMBER WAS NOT PROVIDED AND THE SPECIFIC PRODUCT LOT NUMBER CANNOT BE IDENTIFIED FROM A SHIP HISTORY, THEREFORE IT IS IMPOSSIBLE TO OBTAIN A CERTIFICATE OF CONFORMANCE.

    Description of Event or Problem · 0

    RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 ADAPTOR, THEY COMPLAINED NO POWER TO DEVICE VH-4000.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 ADAPTOR, THEY COMPLAINED NO POWER TO DEVICE VH-4000. NEW ADAPTOR COMPLETE CASE. NO PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 0

    RELATED TO TW (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804470 HEMOPRO2 ADAPTOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC HEMOPRO2 ADAPTOR 00607567700918

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK.| UNKNOWN.