BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO 2 EXTENSION CABLE

    MDR report key: 18923998 · Received March 18, 2024

    Report

    Report Number
    2242352-2024-00257
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 26, 2024
    Report Date
    April 15, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 03/11/2024. AN INVESTIGATION WAS CONDUCTED ON 03/14/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT CORD OR THE INTACT COLLARS. AN ELECTRICAL EVALUATION WAS CONDUCTED. A MECHANICAL EVALUATION WAS CONDUCTED USING A REFERENCE ADAPTOR, POWER SUPPLY AND REFERENCE HEMOPRO 2 DEVICE. THE CABLE WAS ABLE TO BE CONNECTED TO THE ADAPTOR WITH NO PHYSICAL OR VISUAL DIFFICULTIES. THE REFERENCE HARVESTING DEVICE WAS ATTACHED TO THE CABLE WITH NO PHYSICAL OR VISUAL DIFFICULTIES OBSERVED. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE HEMOPRO 2 EVH TOOL, REFERENCE ADAPTER AND REFERENCE POWER SUPPLY SET AT LEVEL 3.0. THE DEVICE PASSED THE PRE-CAUTERY TEST. THE POWER SUPPLY DID EMIT AN AUDIBLE BEEPING SOUND AND THE EVH RETURNED HARVESTING TOOL DID PRODUCE STEAM AND HEAT. THERE WAS NO SMOKE OBSERVED DURING THE TEST. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "ENVIRONMENTAL PARTICULATES- SMOKE" WAS NOT CONFIRMED. THE REPORTED DEVICE IS AN OEM DEVICE. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED FOR THE SERIAL # (B)(6). THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS AND THERE WERE NO NON-CONFORMANCES IDENTIFIED FOR THE MANUFACTURING BATCH.

    Description of Event or Problem · 0

    RELATED TO 992305. THE HOSPITAL REPORTED THAT AFTER AN ENDOSCOPIC VEIN HARVESTING PROCEDURE WAS COMPLETE, HEMOPRO2 EXTENSION CABLE CONNECTION WHERE THE (VH-4030) CORD MEETS THE VH-4000 (HEMOPRO 2) STARTED TO SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150568 HEMOPRO 2 EXTENSION CABLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC C-VH-4030 00607567700925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown