BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2000461 · Received February 14, 2011

    Report

    Report Number
    1124841-2011-00029
    Date Received
    February 14, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE CARDIOPLEGIA TABLE LINE LEAKED. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. 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 CORP. 70151-04 MM18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK