BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STERILE X-COATED DELPHIN PUMP

    MDR report key: 3880144 · Received April 3, 2014

    Report

    Report Number
    1124841-2014-00038
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCED EVAL CONCLUSION. (B)(4). CONCLUSION NOT YET AVAILABLE - EVAL IN PROGRESS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS THE CENTRIFUGAL PUMP LEAKED BLOOD/PLASMA. THERE WAS APPROX ONE DROP EVERY TWO MINUTES OF THE PROCEDURE. APPROX 30 CC BLOOD/PLASMA LOSS. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202796 BULK NON STERILE X-COATED DELPHIN PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 3ZZ164275X QN12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK