BEUDAMED
    FDA Adverse Event Death Summary report: N

    SARNS CENTRIFUGAL PUMP ADAPTER

    MDR report key: 5054637 · Received September 3, 2015

    Report

    Report Number
    1124841-2015-00251
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    July 2, 2015
    Report Date
    October 19, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON SEPTEMBER 3, 2015. BASED ON INFORMATION PROVIDED BY THE USER FACILITY AND ITS CHIEF OF PERFUSION, IT IS BELIEVED THAT THE EVENT WAS NOT CAUSED BY THE TERUMO CARDIOVASCULAR SYSTEMS' MANUFACTURED DEVICE, BUT WAS RATHER A USER ERROR ISSUE; THEREFORE, IT WAS DECIDED THAT AN INITIAL 30-DAY REPORT WOULD BE SUBMITTED TO THE FDA. . ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    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 REFERENCES EVALUATION CONCLUSION. (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 SYSTEMS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER OF THE AFFECTED DEVICE WAS NOT RETURNED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. RETENTION SAMPLES ARE NOT RETAINED FOR CENTRIFUGAL PUMP ADAPTERS; HOWEVER, AN UNLABELED PUMP ADAPTER WAS OBTAINED FOR TESTING PURPOSES. A VISUAL INSPECTION WAS PERFORMED ON THE DEVICE, DURING WHICH NO DAMAGE OR ANOMALIES WERE NOTED. THE DEVICE WAS THEN SET UP ALONG WITH A CENTRIFUGAL PUMP ON A SORIN DRIVER AND THE RPM WAS SET AT 3500. THE DEVICE WITH THE PUMP WAS TESTED IN EACH OF THE 12 LOCKING POSITIONS. DURING EACH ORIENTATION, THE DEVICE AND THE PUMP WERE OBSERVED FOR THE REPORTED DECOUPLING ISSUE. THE ADAPTER DID NOT DECOUPLE FROM THE DRIVER AND THE PUMP DID NOT DECOUPLE FROM THE ADAPTER IN ANY OF THE 12 LOCKING POSITIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AND THE EVENT WAS NOT CONFIRMED. A THOROUGH AND COMPLETE INVESTIGATION COULD NOT BE PERFORMED FOR THIS EVENT AS THE ACTUAL SAMPLE WAS NOT RETURNED AND VERY LITTLE INFORMATION REGARDING THE EVENT WAS RELEASED TO TERUMO BY THE USER FACILITY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    IN EARLY (B)(6), A MANUFACTURER'S SALES REPRESENTATIVE WAS CONTACTED BY THE CHIEF OF PERFUSION AT (B)(6) HOSPITAL REGARDING A PATIENT EXPIRING DURING CARDIOPULMONARY BYPASS. ON (B)(6) 2015, THE CHIEF OF PERFUSION INFORMED TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT THE PERFUSIONIST ON THE CASE (WHO NO LONGER WORKS AT THE USER FACILITY) EXPERIENCED A DISCONTINUITY ISSUE BETWEEN THE TERUMO CENTRIFUGAL PUMP HEAD ADAPTOR AND THE SORIN S5 HEART LUNG MACHINE. THIS IS THE FIRST TIME THE MANUFACTURER'S SALES REPRESENTATIVE WAS AWARE THE MANUFACTURER'S DEVICE WAS INVOLVED IN THE EVENT. THE SAME CENTRIFUGAL PUMP HEAD ADAPTOR WAS USED, AFTER THIS EVENT AND ON A SEPARATE PROCEDURE, WITHOUT ANY ISSUES. FURTHER DETAILS ON THIS CASE ARE UNKNOWN, AND TERUMO IS ATTEMPTING TO GATHER AS MUCH INFORMATION AS POSSIBLE FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583795 SARNS CENTRIFUGAL PUMP ADAPTER CENTRIFUGAL PUMP ADAPTER KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 824043 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death