BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRESSURE TRANSDUCER

    MDR report key: 3113860 · Received May 15, 2013

    Report

    Report Number
    2015691-2013-20077
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE SINGLE FLOTHRU DPT KIT WITH IV SET AND PRESSURE TUBING FOR EXAMINATION. ALL CONNECTIONS APPEARED TIGHT. THERE WAS NO LEAKAGE FOUND FROM THE KIT DURING LEAK TEST. THE FLOW RATE OF THE MERIT FLUSH DEVICE DID NOT MEET IFU SPECIFICATIONS; FLOW MEASURED AN AVERAGE OF 17.3 ML/ WHICH EXCEEDED SPECIFICATION OF 2-4 ML/HOUR. VISUAL EXAMINATION INDICATED THAT BOTH ENDS OF SILICONE HOUSING DID NOT TOUCH THE BASE OF MALE CONNECTOR POCKET AND THIS AFFECTED THE FLOW RATE. LEAK TEST WAS PERFORMED TO THE KIT AT 345MMHG PRESSURE FOR 5 MINUTES. A FLOW RATE TEST WAS PERFORMED TO THE KIT AT 250MMHG PRESSURE FOR 1 HOUR. ROOT CAUSE ANALYSIS AND IMPLEMENTATION OF ANY NECESSARY CORRECTIVE ACTIONS HAS BEEN REQUESTED OF THE SUPPLIER. A SUPPLEMENTAL WILL BE FORTHCOMING WITH THE DEVICE HISTORY RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE AMOUNT OF SALINE REMAINED IN THE SALINE BAG WAS VERY LITTLE AFTER 8 HOURS OF USE. AT 1:58PM ON (B)(6) 2013, THE KIT WITH 500ML OF SALINE MIXED WITH 2ML OF NOVO HEPARIN WAS CONNECTED TO THE PATIENT IN AN OPERATION ROOM. AT 5:45PM, THE PATIENT WAS MOVED TO GICU. AROUND 10:10PM, A NURSE NOTICED THAT THE REMAINING AMOUNT OF SALINE IN THE SALINE BAG WAS VERY LITTLE, ONLY 30ML. CUSTOMER CHECKED THE KIT, BUT THERE WERE NO LEAKAGES CONFIRMED. THEREFORE ABNORMAL FLOW RATE WAS SUSPECTED." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214386 CUSTOM DEFINED PRESSURE TRANSDUCER TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR TC2225S_ POSSIBLE LOT NUMBER IS CC0091M

    Patients

    Seq Age Sex Outcome Treatment
    1