BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 5075900 · Received September 14, 2015

    Report

    Report Number
    2242352-2015-01072
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. NO SGN OF BLOOD OR CLINICAL USE WAS OBSERVED. A COMPLETE KIT WAS RETURNED, NO COMPONENTS WERE MISSING. THE ACCESSORY TRAY INCLUDING THE DISSECTION TIP (BULLET) WAS RETURNED. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT UNABLE TO BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT BEFORE AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, USING VASOVIEW HEMOPRO 2, THEY DIDN'T RECOGNIZE ONE OF THE PARTS IN THE BOX SO WHEN THEY WERE OPENING IT UP ON THE STERILE FIELD, THEY THREW AWAY THE BULLET KIT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT BEFORE AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, USING VASOVIEW HEMOPRO 2, THEY DIDN'T RECOGNIZE ONE OF THE PARTS IN THE BOX SO WHEN THEY WERE OPENING IT UP ON THE STERILE FIELD, THEY THREW AWAY THE BULLET KIT. 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
    605585 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25114788

    Patients

    Seq Age Sex Outcome Treatment
    1