BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON-STERILE X-COATED DELPHIN PUMP

    MDR report key: 3880114 · Received April 3, 2014

    Report

    Report Number
    1124841-2014-00039
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 14, 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
    OTHER HEALTH CARE PROFESSIONAL

    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).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SET UP, THEY CUT OUT THE PUMPS FROM THE CARDIOVASCULAR PROCEDURE KITS (3 PUMPS WERE CUT OUT OF 3 KITS). THE USER DID NOT WANT TO USE LOT QN12 DUE TO PREVIOUS PUMP LEAK COMPLAINTS. NO PT INVOLVEMENT AS THIS OCCURRED DURING SET UP. PRODUCT WAS NOT USED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201651 BULK NON-STERILE X-COATED DELPHIN PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 3ZZ164275X QN12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK