BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AV LOOP KIT

    MDR report key: 3050657 · Received March 14, 2013

    Report

    Report Number
    1319030-2013-00001
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    April 20, 2011
    Report Date
    March 13, 2013
    Manufacturer
    TRANSONIC SYSTEMS, INC.
    Product Code
    DXG
    PMA / PMN Number
    K080116
    Removal / Correction Number
    1319030-2013-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REVIEW OF THIS COMPLAINT WAS DEEMED NOT TO BE REPORTABLE DUE TO NO ADVERSE EVENT TAKING PLACE. DURING ROUTINE INSPECTION NOW TAKING PLACE AT THE MANUFACTURER'S FACILITY, THE FDA INVESTIGATOR RECOMMENDED THAT A MEDWATCH REPORT BE FILED FOR THIS COMPLAINT. NO PATIENT IDENTIFIER INFORMATION IS AVAILABLE DUE TO THE DATE THE INITIAL COMPLAINT WAS RECEIVED AND THE PERSON REPORTING THE COMPLAINT IS NO LONGER EMPLOYED WITH THE COMPANY.

    Description of Event or Problem · 1

    I WANTED TO LET YOU ALL KNOW THAT LAST WEEK AT (B)(6), RIGHT AT THE END OF THE LAST DAY, WE NOTICED THAT THE VENOUS (BLUE) PART OF THE TUBING WAS LEAKING BLOOD-IT HAD A TEAR OR CRACK IN IT. IT LEAKED UNDER THE SENSOR. SEVERAL DIFFERENT NURSES PRACTICED PUTTING THE SENSORS ON, SO I CAN'T SAY IF THEY MAY HAVE CRIMPED THE TUBE IN THE SENSOR (MAYBE MORE THAN ONCE). WE HAD DISCARDED THE PACKAGE. SO I DID NOT HAVE A RECORD OF THE LOT NUMBER/SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108257 AV LOOP KIT TRANSONIC COSTATUS SYSTEM DXG TRANSONIC SYSTEMS, INC. HCS3011 102810

    Patients

    Seq Age Sex Outcome Treatment
    1