BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2112484 · Received April 4, 2011

    Report

    Report Number
    1124841-2011-00152
    Date Received
    April 4, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTR
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    MA-2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY THERE WAS A LEAK IN THE CP50 OF THE CARDIOPLEGIA SET. THE USER FACILITY REPORTED THAT THERE WERE MULTIPLE OCCURRENCES OF THE EVENT; HOWEVER, EVENT INFORMATION WAS ONLY PROVIDED FOR ONE OCCURRENCE. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS APPROXIMATELY 2 CC'S OF BLOOD LOSS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CARDIOVASCULAR PROCEDURE KIT DTR TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA MN15

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK