BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 19929850 · Received August 7, 2024

    Report

    Report Number
    2242352-2024-00906
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 7, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567701250
    PMA / PMN Number
    K153194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW ID# (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 ID#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 07/25/2024. AN INVESTIGATION WAS CONDUCTED ON 08/07/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT BTT. THE BTT WAS RETURNED CONNECTED TO INSUFFLATION TUBING. THE BTT WAS REMOVED FROM THE INSUFFLATION TUBING WITH NO VISUAL OR PHYSICAL DIFFICULTIES OBSERVED. BLOOD WAS OBSERVED ON THE INSUFFLATION PORT OF THE BTT. A SYRINGE WAS USED TO ATTEMPT TO INFLATE THE BALLOON AND THE BTT WAS UNABLE TO BE INFLATED. NO VISUAL OR PHYSICAL DEFECTS WERE OBSERVED ON THE BTT INSUFFLATION TUBING. A 5CC SYRINGE FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT. THE SYRINGE WAS DEPRESSED TO SPRAY THE SALINE. THERE WAS NO BACKFLOW OR OCCLUSION OBSERVED IN THE CO2 LINE. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INSUFFLATION PORT OF THE BTT. THE BTT WAS ABLE TO BE ATTACHED TO THE RETURNED INSUFFLATION TUBING WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "IMPROPER FLOW OR INFUSION" WAS NOT CONFIRMED. THE LOT # 3000401623 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE 2 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 DURING PREPARATION FOR AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 OCCLUSION ALARM SOUNDED WHEN INSUFFLATION TUBING CONNECTED TO BTT PORT; HARVESTERS HAD TROUBLE CONNECTING INSUFFLATION TUBING TO THE BTT PORT. SURGERY PERFORMED IN DIFFERENT OR FROM REGULAR CARDIAC PROCEDURE. HOSPITAL STAFF UTILIZED A STOPCOCK TO CONNECT TUBING AND BTT PORT IN ORDER TO CONNECT TUBING AND PORT. NO FURTHER ALARM SOUNDED AND CASE PROCEEDED WITHOUT ANY DELAY. CASE COMPLETED WITH ORIGINAL DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219573 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-3500 3000401623 00607567701250

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female