BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 6136672 · Received November 30, 2016

    Report

    Report Number
    1212122-2016-00018
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 8, 2016
    Report Date
    February 2, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORDANCE WITH APPLICABLE REGULATIONS - AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED NOVEMBER 30TH, 2016. (B)(4). THE DEVICE WAS DECONTAMINATED 12/14/2016 AND FORWARDED DIRECTLY TO OUR SUPPLIER FOR EVALUATION. OUR SUPPLIER HAS COMPLETED THEIR EVALUATION, AND INDICATED THAT ALTHOUGH A FIBER HADN'T BROKEN, IT WAS CONFIRMED THAT ONE FIBER SHOWED AN EXTREMELY SMALL 2.5MM INTERIOR WALL ABNORMALITY (0.0004% OF THE TOTAL FIBER SURFACE ARE OF THE HEMOCONCENTRATOR). THIS INTERIOR WALL ABNORMALITY OR 'UNDISSOLVED GEL CLOT OF THE POLYMER RAW MATERIAL, COMPROMISED THE INTEGRITY OF THE FIBER WALL HENCE RESULTING IN A VISIBLE LEAK. THE FIBER LEAK WAS CONFIRMED. DUE TO THE INTRICATE STRUCTURE OF THE FIBER USED IN A HEMOCONCENTRATOR, EXTREMELY SMALL ABNORMALITIES SUCH AS THE ONE FOUND WITH THE COMPLAINT UNIT DID NOT LEAK DURING OUR SUPPLIER'S FIBER INTEGRITY TESTING. COMPLAINT WAS LOGGED AND HISTORICAL COMPLAINTS REVIEWED. NO TREND HAS BEEN DETECTED FOR THIS TYPE OF COMPLAINT LOGGED BY OUR SUPPLIER'S CUSTOMERS. NO ADDITIONAL ACTIONS TAKEN BY OUR SUPPLIER. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED, HOWEVER IT HAS NOT BEEN DECONTAMINATED. A REVIEW OF THE DHR WAS PERFORMED AND NO ISSUES WERE NOTED. UPON DECONTAMINATION THE COMPONENT WILL BE FORWARDED TO OUR SUPPLIER FOR FURTHER EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HPH400 HEMOCONCENTRATOR FIBERS WERE BROKEN. THE PERFUSIONIST WAS ON CARDIOPULMONARY BYPASS WITH A PEDIATRIC PATIENT. THEY BEGAN THE HEMOFILTRATION AND IMMEDIATELY NOTED A FIBER LEAK IN THE HEMOFILTER DEVICE. THERE WAS AN ESTIMATED BLOOD LOSS OF 20 CCS. THE BLOOD LOSS WOULD NOT RESULT IN A RISK OF INFECTION BECAUSE THE HEMOFILTER FIBERS WERE LOCATED IN A STERILE HOUSING AND IN A CLOSED LOOP. ADDITIONALLY THE BLOOD LOSS DID NOT RESULT IN THE NEED TO GIVE THE PATIENT A BLOOD TRANSFUSION. PER THE PERFUSIONIST LESS BLOOD WAS GIVEN THAN WHAT IS NORMALLY REQUIRED FOR THE PROCEDURE. THE HEMOFILTER WAS CHANGED OUT WITHOUT ANY DELAY TO THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO OTHER INCIDENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785019 TERUMO CARDIOVASCULAR PROCEDURE KIT CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 74022-01 UL06

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention