BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 4092773 · Received August 20, 2014

    Report

    Report Number
    1212122-2014-00004
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS A DISCONNECTION OF CUSTOMER CONNECTION. NO TRANSFUSION WAS REQUIRED BY THE PT. THE CUSTOMER CONNECTION WAS DUE TO THE FACT THAT A PRE-CONNECTED TIE BAND HAD BROKEN AND WAS DISCOVERED OUT OF BOX. A PHOTOGRAPH OF THE BROKEN TIE BAND WAS PROVIDED BY THE PERFUSIONIST. THE PHYSICAL SAMPLE WAS NOT RECEIVED AND THEREFORE WE WERE UNABLE TO CONFIRM IF THE TOOTH WITHIN THE RATCHET BOX HAD BROKEN OR OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE TIE BAND FAILURE. THE CUSTOMER HAS REQUESTED AND APPROVED A SPECIFICATION CHANGE TO IMPROVE THE CONNECTION STRENGTH. THIS COMPLAINT WILL BE INCLUDED IN ASSOCIATED AWARENESS TRAINING. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING AND TRENDING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 THAT TIE BANDS THAT ARE ON THE SILICONE [TUBING THAT IS PLACED IN THE PUMP] RACEWAY WERE BROKEN OFF AND LAYING IN THE TRAY. CUSTOMER USED THEIR OWN TIE BANDS FOR THE CASE. DURING THE CASE THE TIE BAND [TUBING] DISCONNECTED ABOUT 30 MINUTES INTO THE PUMP RUN. ON (B)(6) 2014 THE CUSTOMER REPORTED THERE WAS APPROX 200-250 ML BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500584 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 74837-02 RF12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention