BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO 2 ADAPTOR

    MDR report key: 9739139 · Received February 21, 2020

    Report

    Report Number
    2242352-2020-00171
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    January 28, 2020
    Report Date
    February 17, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTIONS: D-1 - BRAND NAME; D-4 - VERSION OR MODEL # & CATALOG #, G-5 - PMA/510(K)# CORRECTED D-1 FROM "VASOVIEW HEMOPRO 2" TO "HEMOPRO 2 ADAPTOR" CORRECTED D-4 FROM "VASOVIEW HEMOPRO 2" TO "HEMOPRO 2 ADAPTOR"; CATALOG FROM "VH-4000" TO "VH-4020" CORRECTED G-5 FROM "K101274" TO BLANK. UPDATED SECTIONS: G-4, G-7, H-2, H-3, H-6, H-10. INTERNAL COMPLAINT NUMBER: TW #(B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE PRODUCT IS NOT RETURNING. A LOT NUMBER WAS NOT PROVIDED AND THE SPECIFIC PRODUCT SERIAL NUMBER CANNOT BE IDENTIFIED FROM A SHIP HISTORY, THEREFORE IT IS IMPOSSIBLE TO OBTAIN A CERTIFICATE OF CONFORMANCE. H3 OTHER TEXT : DEVICE NOT RETURNING.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2. STAFF OPENED THE HP2 TO START A CASE AND REALIZED THE CABLE ADAPTER WAS MISSING FROM THE POWER SUPPLY. A COMPETITIVE DEVICE WAS USED AS BACK UP BECAUSE THE ADAPTER COULD NOT BE LOCATED.THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. DEVICE DISCARDED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2. STAFF OPENED THE HP2 TO START A CASE AND REALIZED THE CABLE ADAPTER WAS MISSING FROM THE POWER SUPPLY. A COMPETITIVE DEVICE WAS USED AS BACK UP BECAUSE THE ADAPTER COULD NOT BE LOCATED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202047 HEMOPRO 2 ADAPTOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC HEMOPRO2 ADAPTOR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other