BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE STERILE X-COATED DELPHIN PUMP

    MDR report key: 3880102 · Received April 3, 2014

    Report

    Report Number
    1124841-2014-00041
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, 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 CONCLUSION. (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 SQUEALED. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201405 SINGLE STERILE X-COATED DELPHIN PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 164275X QF06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK