BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STER XCOAT DELPH PUMP

    MDR report key: 4706452 · Received April 16, 2015

    Report

    Report Number
    1124841-2015-00098
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    March 31, 2015
    Report Date
    March 31, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Removal / Correction Number
    MD-2015-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS - AND IS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON 04/16/2015. A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR SUBMISSION OF NEW INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    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 REFERENCES EVALUATION CONCLUSION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT DURING CARDIOPULMONARY BYPASS A MINOR LEAK OCCURRED BETWEEN THE TOP HOUSING AND SEPARATOR OF THE CENTRIFUGAL PUMP. THE DEVICE WAS CONTINUED TO BE USED FOR THE REMAINDER OF THE CASE. LESS THAN 10CC BLOOD LOSS; PRODUCT WAS NOT CHANGED OUT; PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255704 BULK NON STER XCOAT DELPH PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 3ZZ164275X TA08

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown