BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HE CONDUCER POTTED (PACKAGED)

    MDR report key: 4114768 · Received September 15, 2014

    Report

    Report Number
    1124841-2014-00142
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT 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 CORP. THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CONDUCER FROM THE CARDIOVASCULAR PROCEDURE KIT LEAKED. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569368 HE CONDUCER POTTED (PACKAGED) CARDIOVASCULAR PROCEDURE KIT KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 140994 RE10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK