BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NS RX25RE OX W/ RES

    MDR report key: 5166676 · Received October 21, 2015

    Report

    Report Number
    1124841-2015-00284
    Event Type
    Injury
    Date Received
    October 21, 2015
    Date of Event
    October 7, 2015
    Report Date
    December 17, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTZ
    PMA / PMN Number
    K130333
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED BY TERUMO ON NOVEMBER 2, 2015. THE INVESTIGATION HAS YET TO BE COMPLETED. A 2ND FOLLOW UP SHALL BE SUBMITTED TO THE FDA WHEN THE INVESTIGATION IS COMPLETE AND/OR WHEN MORE INFORMATION BECOMES AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE ACTION SAMPLE REVEALED NO ANOMALIES, INCLUDING A CRACK, THAT WOULD HAVE CONTRIBUTED TO THE LEAK EXPERIENCED BY THE CUSTOMER. THE BCP PORT WAS CONNECTED TO A TUBE (THE TUBE DID NOT GO OVER THE THREAD OF THE SCREW ON THE PORT) AND THE JOINT WAS FIXED WITH A TIE-BAND. THE BLOOD PATHWAY WAS FILLED WITH SALINE SOLUTION AND A PRESSURE OF 2.0 KGF/CM2 WAS APPLIED FROM THE BLOOD INLET PORT SIDE. NO LEAK OCCURRED AT THE JOINT BETWEEN THE BCP PORT AND THE TUBE. THE BCP PORT WAS THEN CONNECT TO A TUBE (THE TUBE WAS POSITIONED OVER THE THREAD OF THE SCREW ON THE PORT) AND THE JOIN WAS FIXED WITH A TIE-BAND. THE BLOOD PATHWAY WAS FILLED WITH SALINE SOLUTION AND A PRESSURE OF 2.0 JGF/CM2 WAS APPLIED FROM THE BLOOD INLET PORT SIDE. A LEAK OCCURRED AT THE JOINT BETWEEN THE BCP PORT AND THE TUBE. MAGNIFYING INSPECTION OF THE BCP PORT DID NOT REVEAL ANY ANOMALY, SUCH AS A DEFORMITY, IN APPEARANCE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO PRODUCTION RELATED ANOMALIES. BASED ON THE INVESTIGATION FINDINGS, AS A CAUSE OF THE REPORTED LEAK, IT IS INFERRED THAT: 1, THE TUBE HAS BEEN FIXED TO THE PORT OVER THE THREAD OF THE SCREW ON THE PORT, AND 2, THE TUBE WAS SUBJECTED TO A PULLING FORCE DUE TO BEING TIE-BANDED, CREATING WEAKNESS BETWEEN THE TUBE AND THE BCP PORT. THE EVENT WAS ABLE TO BE REPLICATED. . PER THE RX IFU, "REGULARLY CHECK ALL TUBING CONNECTIONS AND PORTS FOR LOOSENESS OR LEAKAGE." (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AND/OR MORE INFORMATION BECOMES AVAILABLE. (B)(4). CONCLUSIONS: CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS. 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 CORPORATION THAT DURING CARDIOPULMONARY BYPASS THE CARDIOPLEGIA LINE "BLEW OFF" RESULTING IN 500 ML BLOOD LOSS AND A ONE MINUTE PROCEDURE DELAY. ADDITIONAL INFORMATION OBTAINED FROM THE USER FACILITY INDICATED THAT ABOUT 2 HOURS INTO CPB, AS THE PATIENT WAS BEING REWARMED, A RECIRCULATION LINE THAT HAD BEEN PREVIOUSLY TIE-BANDED TO THE CARDIOPLEGIA PORT CAME DISCONNECTED CAUSING BLOOD TO SPRAY FROM THE PORT RESULTING IN APPROXIMATELY 500ML BLOOD LOSS. THE TUBING WAS PUSHED BACK ON THE CONNECTOR BUT IT KEPT SLIPPING OFF. A NURSE WAS ASKED TO HOLD THE TUBING ON THE CONNECTOR AS A NEW TIE BAND WAS PLACED. THE CPB CIRCUIT WAS CHECKED TO FOR AIR AND THEN CPB RESUMED. AT THE TIME OF THE EVENT, THE ARTERIAL FLOW RATE WAS ABOUT 6 L/MIN AND NO CARDIOPLEGIA WAS BEING GIVEN. REPORTEDLY THERE WAS NO HIGH PRESSURE EVENT OBSERVED AND NO KNOWN ISSUE WITH CLOTTING (ACT > 600 SECONDS). THERE WAS NO ISSUE WITH THE SARNS 8000 PERFUSION SYSTEM AS WELL AS NO OBSERVED PROBLEM WITH LINE PRESSURE MEASUREMENT AND/OR PRESSURE LIMITATION FUNCTIONALITY OF THE ARTERIAL MONITOR. NO OTHER ISSUES WERE OBSERVED WITH THE CPB CIRCUIT OR SARNS 8000 FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT WAS WEANED FROM CPB WITHOUT ISSUE AND WAS ALERT AND RESPONSIVE LATER IN THE DAY IN ICU. THE SURGERY WAS COMPLETED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695168 NS RX25RE OX W/ RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP 3ZZ*RX25RE TG08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention