BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STERILE X-COATED DELPHIN PUMP

    MDR report key: 3810751 · Received March 21, 2014

    Report

    Report Number
    1124841-2014-00030
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCED EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP LEAKED PRIME FLUID. THE UNITE WAS CHANGED OUT, AND THE SECOND PUMP ALSO LEAKED. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169363 BULK NON STERILE X-COATED DELPHIN PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 3ZZ164275X QN12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK