BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 15932655 · Received December 7, 2022

    Report

    Report Number
    2242352-2022-00999
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    October 21, 2022
    Report Date
    December 30, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 12/08/2022. AN INVESTIGATION WAS CONDUCTED ON 12/14/2022. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND SLIGHT EVIDENCE OF BLOOD WAS OBSERVED ON THE TRANSECTED AND MELTED C-RING. THE SCOPE WASH TUBING AND THE C-RING REMAINED ATTACHED TO THE CANNULA DUE THE PRESENCE OF A RETENTION RIB. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED FAILURE "BREAK; C-RING" WAS CONFIRMED. THE LOT #3000268642 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS , REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. [NCMR #17521- A NOTIFICATION WAS RECEIVED FROM GXO THAT 2 STERILE LOADS CAME TO THEIR FACILITY WITH EXTERNAL DAMAGE. DURING THE INBOUND INSPECTION 2 OUT OF 500 UNITS FOR MATERIAL VH-4000 BATCH # 3000268642 AND 2 OUT OF 500 UNITS FOR MATERIAL # VH-4000, BATCH # 3000263853 WERE FOUND DAMAGED.. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(6). 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 · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW HEMOPRO 2 HOUSING/ C-RING BROKE. THE VERY TIP, IT BROKE IN HALF. THERE WERE NO PIECES NEEDING TO BE RETRIEVED FROM THE TUNNEL. A NEW DEVICE WAS OPENED TO FINISH THE CASE. NO PATIENT INJURY OR PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814202 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 3000268642 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male