BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1011969 · Received March 12, 2008

    Report

    Report Number
    1124841-2008-00007
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - 208 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION THE INVOLVED SAMPLE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION CONFIRMED THERE WERE NO DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE PACK WAS BUILT TO CUSTOMER SPECIFICATIONS AND DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS BEEN REPORTED PREVIOUSLY. THE INVOLVED CONNECTION WAS MADE BY THE USER FACILITY DURING SET-UP. THE CONVENIENCE KIT LABELING DOES STATES, "BAND ALL CONNECTIONS IN THE CIRCUIT" AND RECOMMENDS TO CAREFULLY OBSERVE CONNECTIONS BEFORE AND CONTINUOUSLY DURING USE. IN ADDITION, THE OXYGENATOR IFU INCLUDED WITH THE TUBING PACK STATES, "BAND ALL CONNECTIONS IN THE CIRCUIT." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE WITH QUALITY MANAGEMENT FOR TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A BYPASS PROCEDURE, THE TUBING LINE BECAME DISCONNECTED FROM THE VENOUS RESERVOIR WHERE IT HAD BEEN ATTACHED BY THE USER. THE REPORTED BLOOD LOSS WAS ESTIMATED TO BE 200-CC. THE USER FACILITY REPORTED THAT THERE WAS NO PATIENT INJURY, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT TUBING CONVENIENCE KIT DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. NA HM01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK