BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 17863215 · Received October 3, 2023

    Report

    Report Number
    2242352-2023-00819
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 4, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW ID# 891600. THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 09/22/2023. AN INVESTIGATION WAS CONDUCTED ON 09/26/2023. A VISUAL INSPECTION WAS CONDUCTED. BOTH THE CANNULA AND THE HARVESTING DEVICE WAS RETURNED FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE INTACT CANNULA. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT CANNULA. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE HARVESTING DEVICE. CHARRED MATERIAL WAS OBSERVED ON THE INTACT HEATER WIRE. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT HEATER WIRE OR THE INTACT SILICONE INSULATION. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST WAS PERFORMED PER THE DIRECTION FOR USE (DFU) WITH A REFERENCE CABLE, ADAPTER, AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 3.0. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM AND HEAT DURING TEN (10) 3-SECOND ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. TO EVALUATE THE SAFETY SHUT DOWN SYSTEM, A POLYFUSE ACTIVATION TEST WAS PERFORMED 5 TIMES OVER 10 MINUTES. THE DEVICE SHUT OFF AFTER THE PERIOD OF SUSTAINED ACTIVATION AND REACTIVATED AFTER 10-SECOND COOLING PERIOD WITH NO INCIDENT EACH TIME. AN ACTIVATION AND TRANSECTION CAPABILITY TEST WAS PERFORMED OVER FOUR (4) REPETITIONS USING "MAX LIFE TEST METHOD STM2048073 REV AA. THE DEVICE SUCCESSFULLY TRANSECTED TISSUE FOUR (4) TIMES. THE JAWS WERE GENTLY CLEANED OF DEBRIS AND CHAR WITH A SALINE AND GAUZE PAD AS INDICATED IN THE DIRECTION FOR USE (CV000008979). A TEMPERATURE AND RESISTANCE TEST WAS CONDUCTED TO EVALUATE THE DEVICE FUNCTION PER HEMOPRO 2 FINAL TEST 90523436 REV W. THE RESISTANCE VALUE WAS MEASURED AT .60 OHMS WHICH IS WITHIN SPECIFICATION. THE DEVICE PASSED THE TEMPERATURE MEASUREMENTS TEST. THE DISPLAYED TEMPERATURE INCREASED AND TURNED GREEN WITHIN THE 2 SECOND SPECIFIED TIMEFRAME. THE DISPLAYED TEMPERATURE DECREASED ONCE THE TOGGLE SWIVEL WAS RELEASED. BASED ON THE RETURNED CONDITION OF THE DEVICE, AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "FAILURE TO DELIVER ENERGY" WAS NOT CONFIRMED . THE LOT # 3000331132 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 WITH THE BATCH MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    RELATED RECORD: 891604. HOSPITAL REPORTED VASOVIEW HEMOPRO 2 WOULD NOT WORK (TRANSFERENCE OF ENERGY FROM THE BOX TO THE DEVICE). THE DEVICE STARTED TO CAUTERIZE AND SUBSEQUENTLY STOPPED. TO TROUBLE SHOOT THE ISSUE, THE CUSTOMER REPLACED THE HP2 CORD AND THE DEVICE STILL DID NOT WORK. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THE ONLY PROCEDURAL DELAY WAS LIMITED TO THE REOPENING OF A NEW DEVICE WHICH WORKED PROPERLY. NO INJURY OR HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760909 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000331132 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HP 2 CORD