BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 11866613 · Received May 21, 2021

    Report

    Report Number
    2242352-2021-00403
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 16, 2021
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). CORRECTED SECTION: H3- CORRECTED TO "DEVICE DISCARDED." ANALYSIS OF PRODUCTION: (3331/213/67/3221) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT 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 MANUFACTURING PROCESS AND THE REPORTED FAILURE MODE. HISTORICAL DATA ANALYSIS: (4109/213/67/3221) THERE WERE 1 ADDITIONAL SIMILAR COMPLAINT(S) REPORTED FOR THE REPORTED FAILURE MODE AND THE REPORTED LOT NUMBER. A REVIEW OF THE PRODUCT COMPLAINT TREND DATA WAS PERFORMED FOR THE MONTHS OF (JAN 2021¿ THROUGH ¿APR 2021). THE REVIEW DOES NOT IDENTIFY AN INCREASING TREND OR AN ADVERSE TREND FOR THREE CONSECUTIVE MONTHS FOR THE PRODUCT FAMILY AND THE FAILURE MODE. TREND ANALYSIS: (4110/213/67/3221) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD JUN 2019 THROUGH MAY 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.

    Description of Event or Problem · 0

    ADDITIONAL COMPLAINT RECORD HAS BEEN CREATED DUE TO UNRELATED FAILURE MODE (S) TW ID (B)(6).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ADDITIONAL COMPLAINT RECORD HAS BEEN CREATED DUE TO UNRELATED FAILURE MODE (S) TW ID (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2. THERE WAS LOSS OF TRANSFER OF POWER. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762641 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25150499 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.