BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 23437872 · Received October 31, 2025

    Report

    Report Number
    2242352-2025-0001166
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Report Date
    November 14, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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). UPDATED FIELD: B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 10/03/2025. AN INVESTIGATION WAS CONDUCTED ON 10/14/2025. A VISUAL INSPECTION WAS CONDUCTED. ONLY THE BTT WAS RETURNED FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT BTT. THE BTT WAS ABLE TO BE INFLATED. NO VISUAL DEFECTS WERE OBSERVED ON THE SILICONE BTT. A 5CC SYRINGE, FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT AND SQUEEZED THE SYRINGE TO SPRAY THE SALINE. THERE WAS NO BACKFLOW OBSERVED IN THE CO2 LINE. BASED ON THE RETURNED CONDITION OF THE DEVICE AND NO SPECIFIC FAILURE REPORTED, THERE WERE NO FAILURE OBSERVED. THE LOT # 3000471816 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 BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT THEY WERE HAVING ISSUES WITH THE VASOVIEW HEMOPRO 2. THEY ARE ERRORING WHEN THEY PLUG THEM IN, WHICH IS MAKING THEM UNUSABLE. THEY THOUGHT IT WAS THE MACHINE BUT WHEN WE SWITCH TO A DIFFERENT LOT IT WILL NOT ERROR. THEY DON'T KNOW IF THERE IS PATIENT EFFECT, IF THE PATIENT IS IN THE ROOM OR ANY MORE INFORMATION AT THE TIME. THEY CAN CONFIRM THAT WHEN USING A DIFFERENT LOT NUMBER OF THE DISPOSABLE THE DEVICE SEEMS TO WORK AS DESIGNED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562184 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000471816 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown