BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 5100735 · Received September 24, 2015

    Report

    Report Number
    1828100-2015-00825
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    August 31, 2015
    Report Date
    November 12, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SOFTWARE DATA LOGS WERE RECEIVED BY THE MANUFACTURER ON 2-SEP-2015 FOR FURTHER EVALUATION. PER THE CUSTOMER, THEY ASKED TO HAVE THE FSR PERFORM AN OPERATIONAL AND VERIFICATION TESTING ON THE SYSTEM-1. THE FSR PERFORMED A FULL PREVENTIVE MAINTENANCE (PM) ON THIS SYSTEM-1 BUT DID NOT CHANGE ANY PARTS. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE.

    Additional Manufacturer Narrative · 1

    CLOTS WERE NOTED IN THE FRESENIUS CATS CELL WASHING CIRCUIT. A SEARCH OF THE MAUDE DATABASE ON 14-OCT-2015 AND FDA MDR #MW5056130 RECEIVED ON 26-OCT-2015 WERE DETERMINED TO BE THE SAME REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. THERE IS NO PRODUCT DEFICIENCY OF THE SYSTEM-1 AS THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A FULL PREVENTIVE MAINTENANCE (PM) OF THE UNIT AND THE UNIT OPERATED TO MANUFACTURERS SPECIFICATIONS. THE SYSTEM-1 HAS BEEN USED AT THE USER FACILITY SINCE THIS EVENT WITH NO ISSUES. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO RE-ESTABLISH ON CARDIOPULMONARY BYPASS (CPB) THERE WAS AN INCIDENT WITH THE SYSTEM-1. AS A RESULT, AN ALTERNATE SYSTEM WAS EMPLOYED. THIS EVENT CAUSED ABOUT A 20 MINUTE DELAY IN THE OPERATING ROOM (O/R). BLOOD LOSS WAS ESTIMATED TO BE ABOUT 4000 MILLILITER (ML). THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT EXPIRED ON MONDAY, (B)(6) 2015. PER THE CLINICAL REVIEW ON 9-SEP-2015: MANUFACTURE'S CLINICAL SERVICE VISITED AND SPOKE TO THE PERFUSIONIST (CCP) AND RISK MANAGER (RN, MSN). THE PATIENT WAS A (B)(6) MALE AND THE PERFORMED SURGICAL PROCEDURE WAS AN AORTIC VALVE REPLACEMENT (AVR) WITH AORTIC REPAIR AND A MITRAL VALVE REPLACEMENT (MVR). THIS PATIENT HAD PREVIOUS CARDIAC SURGERY IN PAST YEARS. THEIR CPB CIRCUIT INCLUDED A SYSTEM-1 WITH BASE S/N (B)(4). THE CPB CIRCUIT WAS PACK #B-8334TXC-06 AND CONTAINED A SARNS CENTRIFUGAL PUMP AND A 3CX*FX25RE OXYGENATOR. TWO CPB CIRCUITS AND TWO DIFFERENT SYSTEM-1S WERE NEEDED TO BE USED IN THE PROCEDURE. THE LOT NUMBER ON BACK OF FIRST CAPIOX VENOUS RESERVOIR (CVR) WAS TE27 AND THE LOT NUMBER ON THE BACK OF THE SECOND CVR WAS TD09. ACCORDING TO CCP, THE PATIENT HAD BEEN ON COUMADIN (WARFARIN), AN ANTICOAGULANT PRIOR TO SURGERY AND ACCORDING TO THE CCP HAD BEEN DISCONTINUED A COUPLE OF DAYS PRE-OP. ON ARRIVAL TO THE OPERATING ROOM ON (B)(6) 2015, THE ACTIVATED CLOTTING TIME (ACT) WAS 142 SECONDS AND THE HEPARIN DOSE RESPONSE (HDR) WAS 2.4 AND THIS TEST PREDICTS THAT A LOADING DOSE OF 2.4 MILLIGRAM/KILOGRAM (MG/KG) BODY WEIGHT LOADING DOSE OF HEPARIN IS REQUIRED. ACCORDING TO THE CCP, THE PATIENT DEMONSTRATED SIGNS OF HYPERCOAGULABILITY BEFORE CPB AND THUS A LOADING DOSE OF HEPARIN OF 3.5 MG/KG (40,000 UNITS) WAS GIVEN PRIOR TO THE FIRST PUMP RUN AND AN ADDITIONAL 10,000 UNITS OF HEPARIN WAS IN THE PRIME SOLUTION. PRIOR TO CPB, CLOTTING WAS OBSERVED ON THE SWAN-GANZ CATHETER DURING PLACEMENT AND CLOTTING WAS ALSO SEEN IN A BLOOD COLLECTION BAG WHICH CONTAINED ACID CITRATE DEXTROSE (ACD) AS WHOLE BLOOD WAS COLLECTED FROM A CENTRAL IV LINE PRIOR TO CPB (PER THEIR NORMAL PRACTICE). ACCORDING TO THE CCP, CLOTTING IS NOT USUALLY OBSERVED DURING THESE MANEUVERS. THERE WERE NO ISSUES DURING THE FIRST CPB PERIOD. THE PUMP TIME WAS ABOUT TWO HOURS AND 50 MINUTES. THERE WERE NO ISSUES WITH GAS TRANSFER AND NO ISSUES IN THE ABILITY TO PRODUCE THE TARGET BLOOD FLOW RATES. REVOLUTIONS PER MINUTE (RPM) / FLOW RELATIONSHIPS WERE WITHIN EXPECTED LEVELS. AFTER THE INITIATION OF CPB, THE FIRST ACT WAS 589 SECONDS AND THE HEPARIN LEVEL WAS AT TARGET LEVEL OF 3.5 MG/KG. THE ACT GRADUALLY DROPPED DURING THE FIRST CPB PERIOD, AND ADDITIONAL HEPARIN WAS GIVEN AS NEEDED. IN THE LAST 45 MINUTES OF CPB, THE ACT RANGED FROM 405 SECONDS TO 465 SECONDS WITH ADDITIONAL 15,000 UNITS OF HEPARIN GIVEN DURING THIS PERIOD. AGAIN, NO ISSUES OBSERVED REGARDING GAS TRANSFER OR BLOOD FLOW. THE HEPARIN LEVEL WAS AS LOW AS 2.5 MG/KG DURING CPB. THE PATIENT WAS WEANED FROM CPB, WITHOUT ISSUE AND WITH ADEQUATE HEMODYNAMICS (BLOOD PRESSURE AND ELECTROCARDIOGRAM [ECG] RHYTHM). AFTER TRANSFUSING REMAINING VOLUME IN THE CVR, THE CCP ESTIMATED THERE WAS ABOUT 100 ML OF BLOOD IN THE RESERVOIR. PER THE CCP, IT IS STANDARD PERFUSION PRACTICE TO KEEP THE SUCKER ROLLER PUMP ROTATING AFTER CPB FOR A PERIOD OF TIME. WHEN PROTAMINE IS STARTED, IT IS THE RESPONSIBILITY OF THE SURGICAL FIELD STAFF TO ISOLATE AND STOP USING THE PUMP SUCKERS AND TRANSITION OVER TO THE CELL SAVER SUCKER. AFTER THE PATIENT WAS WEANED FROM CPB, THE CCP WAS DOING SOME CHARTING ABOUT THREE TO FOUR MINUTES AFTER THE COMPLETION OF CPB, AND IT WAS ANNOUNCED THE PATIENT WAS BLEEDING (RIGHT ATRIAL TEAR) AND IT MIGHT BE REQUIRED FOR CPB TO BE RE-INITIATED. THE CCP LOOKED DOWN AT THE VENOUS RESERVOIR, AND HE SAW THERE WAS 4000 ML IN THE RESERVOIR (ONLY 100 ML LEFT AT END OF CPB). IT APPEARS THE PUMP SUCKERS WERE BEING USED, AND PROTAMINE MAY HAD BEEN STARTED. THE CCP STATED HE DID NOT HEAR THE COMMAND TO START THE PROTAMINE, BUT HE CAN NOT RULE OUT THAT POSSIBILITY. THE CARDIOVASCULAR (CV) SURGEON ORDERED THE ANESTHESIOLOGIST TO GIVE A RE-LOADING DOSE OF HEPARIN IN PREPARATION FOR CANNULATION AND EMERGENT RETURN TO CPB. THE INITIATION OF CPB WAS ATTEMPTED AT ABOUT SEVEN MINUTES AFTER THE INITIAL WEANING OF CPB, BUT THE CCP WAS NOT ABLE TO GENERATE ARTERIAL BLOOD FLOW IN SPITE OF PUMP SPEEDS OF ABOUT 2000 RPM. CLOTS WERE SEEN IN THE OXYGENATOR / RESERVOIR AND INITIALLY THE PLAN WAS TO CHANGE OUT THE OXYGENATOR / CVR ONLY. AFTER ADDITIONAL CONSIDERATIONS, THE CLINICAL TEAM ELECTED TO BRING IN A COMPLETELY NEW CPB CIRCUIT THAT WAS SET-UP AND USED ON A DIFFERENT SYSTEM-1. THIS REQUIRED SET-UP AND PRIMING AND THE RE-INITIATION OF CPB WAS DELAYED ABOUT 20 MINUTES. THE 4000 ML OF BLOOD THAT REMAINED IN THE ORIGINAL CPB CIRCUIT WAS NOT ABLE AND NOT CHOSEN TO BE TRANSFERRED AND USED IN THE SECOND CIRCUIT. THUS, BLOOD LOSS IS ESTIMATED TO BE ABOUT 4000 ML. THE SECOND CPB PERIOD WAS WITHOUT OBSERVED ISSUES AND THERE WERE NO ISSUES WITH GAS TRANSFER AND / OR ARTERIAL FLOW RATES. THE PATIENT WAS WEANED FROM CPB SUCCESSFULLY, BUT AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED TO AUGMENT CORONARY AND CEREBRAL BLOOD FLOW POST CPB (ACCORDING TO THE CCP). ACTS REMAINED AT > 750 SECONDS THE SECOND CPB PERIOD. WHEN THE CPB CIRCUIT WAS DRAINED POST CPB, CLOTS WERE SEEN AT THE BASE OF THE SECOND CVR. THE SYSTEM-1 UNIT WAS INSPECTED AND TESTED BY THE FIELD SERVICE REPRESENTATIVE (FSR) THE FOLLOWING DAY. ACCORDING TO THE FSR, A FULL PREVENTIVE MAINTENANCE (PM) INSPECTION WAS COMPLETED AND THE SYSTEM-1 OPERATES TO MANUFACTURER SPECIFICATIONS .THE SOFTWARE DATA LOGS WERE COLLECTED AND ANALYZED BY MANUFACTURER TECHNICAL SUPPORT. THIS PERFUSION SYSTEM HAS BEEN USED AT (B)(6) SINCE THIS EVENT. PER MEETING WITH THE CCP AND RISK MANAGER ON 9-SEP-2015, IT WAS DISCOVERED THE PATIENT EXPIRED ON (B)(6) 2015 AT 3:24 PM. THE CASE WAS COMPLETED, AS SCHEDULED BUT THERE WAS ABOUT A 20 MINUTE DELAY IN THE PROCEDURE AND IN THE RE-INITIATION OF CPB. BLOOD LOSS WAS ESTIMATED AT ABOUT 4000 ML. THERE IS NO INFORMATION GATHERED FROM SYSTEM-1 INSPECTION, LOG ANALYSIS, OXYGENATOR AND PUMP FUNCTIONS DURING FIRST CPB PERIOD (ALMOST THREE HOURS) THAT ILLUSTRATES FUNCTIONAL ISSUES WITH THE SYSTEM-1 OR CPB CIRCUIT COMPONENTS. CLOTTING WAS OBSERVED IN THE CPB CIRCUIT AND THE MOST LIKELY CAUSE OF NOT BEING ABLE TO PROVIDE ARTERIAL FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631054 TERUMO ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R CAPIOX VENOUS RESERVOIR, LOT TE27