BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 22932044 · Received September 2, 2025

    Report

    Report Number
    2242352-2025-0001007
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW # (B)(4). UPDATED SECTIONS: B4,B5,G3,G6,H2,H3,H6,H11. CORRECTED SECTION: H6-IMPACT CODE CHANGED TO 2199. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 08/22/2025. A INVESTIGATION WAS CONDUCTED ON 08/26/2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND BLOOD WAS OBSERVED ON THE INTACT BTT. THE SCOPE SEAL WAS ALSO RETURNED FOR EVALUATION. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT BTT. 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 THE REPORTED FAILURE "INFUSION OR FLOW PROBLEM" WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: B4,B5,G3,G6,H2,H,6H11.

    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.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED INSUFFLATOR KEPT ALARMING SAYING THERE WAS AN OCCLUSION. THE ENTIRE BTT PORT WAS REPLACED. THE REPLACEMENT BTT WAS TAKEN FROM AN ACCESSORY KIT. AFTER THE BTT WAS REPLACED, THE ERROR MESSAGE STOPPED. NO KINKS IN TUBING, NOT SURE OF SETTINGS OF CO2. THE BTT WAS PROPERLY INFLATED. EVERYTHING WAS DISCONNECTED AND RECONNECTED AND ERROR MESSAGE WENT AWAY. THERE WAS A MINIMAL DELAY. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED INSUFFLATOR KEPT ALARMING CONSULTATION CFA SWITCHED OUT GREY SEAL ON HEMOPRO AND INSUFFLATOR STOP ALARMING. NO KINKS IN TUBING, NOT SURE OF SETTINGS OF CO2. THE BTT WAS PROPERLY INFLATED. IT WAS SAYING THERE WAS AN OCCLUSION. EVERYTHING WAS DISCONNECTED AND RECONNECTED AND ERROR MESSAGE WENT AWAY. THERE WAS A MINIMAL DELAY. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED INSUFFLATOR KEPT ALARMING CONSULATION CFA SWITCHED OUT GREY SEAL ON HEMOPRO AND INSUFFLATOR STOP ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866129 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000489864 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.