BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1667472 · Received April 22, 2010

    Report

    Report Number
    1212122-2010-00004
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    March 31, 2010
    Report Date
    March 31, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL SUSPECT DEVICE NOR HAD ANY EXISTING INVENTORY IN STOCK TO EVALUATE. TERUMO IS AWARE THAT THE DISCONNECTION OCCURRED AT A CUSTOMER CONNECTION AND THAT NO TIE BAND WAS UTILIZED AFTER THE CONNECTION WAS MADE. TERUMO IS AWARE THAT THE PT LOST 1 LITER OF BLOOD, AND LATER EXPIRED DUE TO AN UNMANAGEABLE COAGULOPATHY AND MASSIVE CONTINUED BLEEDING. TERUMO IS AWARE OF THE SEVERE RISK ASSOCIATED WITH HAVING AN ARTERIAL LINE SEPARATE AND THAT IT COULD BE LIFE THREATENING; HOWEVER, IN THIS EVENT, THE FAILURE DID NOT LEAD TO THE PT'S POOR OUTCOME. (B) (4)

    Description of Event or Problem · 1

    ON (B) (6) 2010, TERUMO CARDIOVASCULAR WAS INFORMED THAT DURING CARDIOPULMONARY BYPASS SURGERY, THERE WAS A LINE DISCONNECTION IN THE ARTERIAL LINE LOCATED AT THE CUSTOMER MADE TUBING CONNECTION. IT WAS REPORTED BY THE USER FACILITY THAT THERE WAS APPROX 1 LITER OF BLOOD LOSS AND A 2 1/2 MINUTE DELAY IN RECONNECTING THE DEVICE. THE SURGERY WAS FINISHED AND THE PT WAS WEANED FROM BYPASS WITH DIFFICULTY. THE PT LATER EXPIRED DUE TO AN UNMANAGEABLE COAGULOPATHY AND MASSIVE CONTINUED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK DWF TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA LN23

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death