BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 8881533 · Received August 10, 2019

    Report

    Report Number
    2242352-2019-00927
    Event Type
    Injury
    Date Received
    August 10, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    HQO
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED SECTIONS: B1- CHANGED FROM PRODUCT PROBLEM TO ADVERSE EVENT & PRODUCT PROBLEM, B2-REQUIRED INTERVENTION, B5- DESCRIPTION UPDATED, H1-UPDATED FROM MALFUNCTION TO SERIOUS INJURY THE DEVICE WAS RETURNED TO THE FACTORY ON 17SEP2019 AND EVALUATED ON 14NOV2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. NO VISUAL DEFECTS WERE OBSERVED. THE DEVICE WAS EVALUATED FOR ITS ELECTRICAL FUNCTION ACCORDING TO THE SERVICE MANUAL SECTION D- ¿FUNCTIONAL TESTS¿ USING A PRECISION MULTIMETER AND A 0.62OHM RESISTOR HEMOPRO POWER SUPPLY TEST BOX. THE TEST BOX USES THE 10K OHM RESISTOR THAT IS BUILT INTO THE HEMOPRO CABLE. THE DEVICE PASSED ALL ELECTRICAL TESTS PERFORMED, THE LED LIGHT WAS VISIBLE AND AN INTERMITTENT TONE WAS AUDIBLE WHEN CURRENT WAS BEING MEASURED. NO SMOKE WAS OBSERVED WHEN THE POWER SUPPLY WAS TURNED ON. THE VALUES RECORDED ARE WITHIN TOLERANCE, BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT WAS NOT CONFIRMED. THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW IS NOT APPLICABLE. BASED ON THE SERIAL NUMBER PROVIDED, WE WERE UNABLE TO FIND WHEN THE DEVICE WAS SOLD TO THE ACCOUNT. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS NOT AVAILABLE FOR REVIEW BECAUSE, THE REPORTED SERIAL NUMBER DOES NOT APPEAR TO BE INCLUDED IN ANY OF THE BATCHES RECEIVED IN MAQUET WAYNE."

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, T.W. POWER SUPPLY MALFUNCTIONED. VASOVIEW HEMOPRO ACTIVATED ON ITS OWN. THE PATIENT AND THE SURGEON WERE BOTH BURNED. HOSPITAL ARE NOT SURE WHERE THE BURNS ARE LOCATED ON EITHER THE PATIENT OR THE SURGEON.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, T.W. POWER SUPPLY MALFUNCTIONED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675543 EVH UNIT, CAUTERY, THERMAL, AC-POWERED HQO MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention