BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 21504824 · Received March 3, 2025

    Report

    Report Number
    2242352-2025-0000222
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 3, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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: (B)(4). CORRECTED SECTION - H6 (HEALTH EFFECT ¿ IMPACT CODES). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 02/07/2025. AN INVESTIGATION WAS CONDUCTED ON 03/11/2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT HARVESTING DEVICE INTACT SILICONE INSULATION ON BOTH THE COLD AND HOT JAWS. THE HEATER WIRE WAS OBSERVED TO BE INTACT. THE HARVESTING DEVICE WAS RETURNED WITH THE HP2 EXTENSION CABLE FROM ONETRACK 1221062 ATTACHED. AN ATTEMPT WAS MADE TO REMOVE THE CABLE FROM THE HARVESTING DEVICE. THE DEVICE WOULD NOT DISCONNECT FROM THE CABLE. 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. NO EXCESSIVE SMOKE AND/OR STEAM WERE OBSERVED DURING THE TESTING. 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. THE DEVICE SUCCESSFULLY TRANSECTED TISSUE FOUR (4) TIMES. NO FINAL TESTING WAS CONDUCTED TO THE CABLE NOT BEING REMOVED FROM THE HARVESTING DEVICE. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "CONNECTION PROBLEM" WAS CONFIRMED. THE LOT# THE LOT#: 3000450191 HISTORY RECORD REVIEW WAS COMPLETED. THERE WAS AN NCMR, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. [NCMR#: 18198 A GROWING TREND OF COMPLAINTS (QTY: 4, SINCE JANUARY 2025) HAS BEEN IDENTIFIED INVOLVING SERIOUS INJURIES LINKED TO THE FAILURE OF CERAMIC C-RING ON THE VASOVIEW HEMOPRO 2 DEVICE DURING PROCEDURES. THIS ISSUE POSES A SIGNIFICANT RISK TO PATIENT SAFETY, NECESSITATING IMMEDIATE ACTION TO PREVENT FURTHER HARM WHILE AN INVESTIGATION IS CONDUCTED TO IDENTIFY THE ROOT CAUSE AND IMPLEMENT CORRECTIVE MEASURES]. 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 · 0

    THE HOSPITAL REPORTED THAT THE VASOVIEW HEMOPRO 2 UNABLE TO BE REMOVED FROM HEMOPRO2 EXTENSION CABLE DEVICE AFTER A CASE WAS COMPLETED. IT FELT COMPLETELY STUCK IN THE DEVICE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329736 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000448471 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown