BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 21504672 · Received March 3, 2025

    Report

    Report Number
    2242352-2025-0000221
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 3, 2025
    Report Date
    April 1, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700925
    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 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 SECTION. CORRECTED DATA. 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 NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT CABLE. THE CABLE WAS RETURNED ATTACHED TO THE HARVESTING DEVICE FOR ONETRACK 1230315. AN ATTEMPT WAS MADE TO REMOVE THE CABLE FROM THE HARVESTING DEVICE; HOWEVER, THE CABLE WOULD NOT DISCONNECT FROM THE HARVESTING DEVICE. BASED ON THE RETURNED CONDITION OF THE DEVICES AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "CONNECTION ISSUE" WAS CONFIRMED. THE REPORTED DEVICE IS AN OEM DEVICE, THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. A LOT /SERIAL NUMBER WAS NOT PROVIDED AND THE SPECIFIC PRODUCT LOT /SERIAL NUMBER CANNOT BE IDENTIFIED FROM A SHIP HISTORY, THEREFORE IT IS IMPOSSIBLE TO OBTAIN A CERTIFICATE OF CONFORMANCE

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT HEMOPRO2 EXTENSION CABLE UNABLE TO BE REMOVED FROM HP2 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
    1345150 HEMOPRO2 EXTENSION CABLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4030 00607567700925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.