BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CDI H/S CUVETTE

    MDR report key: 5343133 · Received January 5, 2016

    Report

    Report Number
    1124841-2016-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 16, 2015
    Report Date
    March 10, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    1124841-12/08/2015-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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. (B)(4). CONCLUSION NOT YET AVAILABLE - EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS - AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JANUARY 5, 2016. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: (DEVICE MODEL NUMBER AND EXPIRATION DATE), (DATE RECEIVED BY MANUFACTURER), (INDICATION THAT THIS IS A FOLLOW-UP REPORT), (FOLLOW-UP DUE TO ADDITIONAL INFORMATION), (DEVICE MANUFACTURE DATE). (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION; A RETENTION SAMPLE FROM THE SAME PRODUCT CODE/ LOT NUMBER COMBINATION WAS OBTAINED FOR THE INVESTIGATION. THE RETENTION SAMPLE WAS VISUALLY INSPECTED, DURING WHICH NO ANOMALIES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING ANOMALIES. THE FUNCTIONALITY OF THE CUVETTE AND MAGNET WAS EVALUATED BY CONNECTING THE UNIT TO THE CDI500 MONITOR. IT WAS FOUND TO HAVE NO DIFFICULTIES CONNECTING TO THE MONITOR. THE STRENGTH OF THE SAMPLE'S MAGNET WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE EVENT REPORTED BY THE USER FACILITY COULD NOT BE REPRODUCED; THEREFORE THIS COMPLAINT IS NOT CONFIRMED. THIS EVENT IS ASSOCIATED WITH THE VOLUNTARY SAFETY ALERT DISTRIBUTED BY TERUMO ON DECEMBER 8, 2015, 1124841-12/08/2015-004-C, AND IT WAS CONFIRMED IN OTHER EVENTS THAT ARE ALSO ASSOCIATED WITH THIS SAFETY ALERT, THAT DURING THESE OTHER EVENTS IT IS LIKELY THAT THE MAGNETS WERE DEFECTIVE WITH WEAK MAGNETIC STRENGTHS. THESE MAGNETS ARE MANUFACTURED BY AN OUTSIDE SUPPLIER, ARNOLD MAGNET TECHNOLOGIES. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE USER EXPERIENCED A H/S CUVETTE DISCONNECT ERROR. THIS EVENT IS ASSOCIATED WITH A VOLUNTARY SAFETY ALERT INITIATED BY TERUMO: 1124841-12/08/2015-004-C; THEREFORE, IT IS BEING REPORTED. 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
    5081 CDI H/S CUVETTE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS 6922 TH27

    Patients

    Seq Age Sex Outcome Treatment
    1