BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE STERILE X-COATED DELPHIN PUMP

    MDR report key: 3603240 · Received January 23, 2014

    Report

    Report Number
    1124841-2014-00007
    Event Type
    Death
    Date Received
    January 23, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 4, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    KFM
    PMA / PMN Number
    K020998
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    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. FOR THIS REASON, TERUMO REFERENCED EVALUATION CONCLUSION CODE. (B)(4). EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE ARRIVED IN THE EMERGENCY DEPARTMENT ON (B)(6) 2014 AT 1339 VIA EMS FOR FURTHER EVALUATION AND TREATMENT OF NON-Q-WAVE MYOCARDIAL INFARCTION AND SHORTNESS OF BREATH FOR SEVERAL MONTHS. PT HAD A LEFT HEART CATHETER ON (B)(6) 2014. THE PT WAS SCHEDULED FOR AN URGENT CORONARY ARTERY BYPASS GRAFT (CABG) X3 PROCEDURE. AN INTA-AORTIC BALLOON PUMP WAS PLACED IN THE PT PRIOR TO SURGERY. CEREBRAL OXIMETRY WAS USED DURING THE PROCEDURE, AND CEREBRAL SATURATIONS WERE LOW (30 PERCENT BELOW BASELINE IN SPITE OF INCREASING THE BLOOD FLOW RATE, ELEVATING PCO2 LEVELS AND KEEPING PAO2 LEVELS HIGH) BOTH PRIOR TO AND DURING CARDIOPULMONARY BYPASS (CPB). THE PT WAS HYPOTENSIVE THROUGHOUT CPB AS THE PERFUSION PRESSURE WAS 30-50 MMHG IN SPITE OF LARGE DOSES OF NEOSYNEPHRINE AND LEVOPHED. THE CENTRIFUGAL PUMP MOTOR WAS RUNNING AT 1700 RPM SINCE 2 PM ON (B)(6) 2014 (TWO DAYS PRIOR TO THIS EVENT). THE CPB CIRCUIT WAS ASSEMBLED FOR A DIFFERENT PROCEDURE ON THAT DATE, BUT WAS NOT NEEDED; THEREFORE, THE CIRCUIT WAS SAVED AND THE PRIME SOLUTION WAS RECIRCULATED WITHIN THE CIRCUIT BY THE CENTRIFUGAL PUMP HEAD OVER TWO DAYS. THE SAVED CIRCUIT WAS USED FOR THIS EVENT (ON (B)(6) 2014), DESPITE OPERATING AT 1700 RPM FOR TWO DAYS. APPROXIMATELY 70-80 MINUTES INTO CPB, THERE WAS A BACKFLOW ALARM - SYSTEM-1 LOGS REVEAL THE RPM REMAINED CONSTANT (AT 1500 RPM) APPROXIMATELY 4 MINUTES PRIOR TO THE ALARM AND ANOTHER 5 SECONDS AFTER THE ALARM SOUNDED. AFTER THE ALARM, THE VENOUS RESERVOIR BEGAN TO FILL, AND THE PT PRESSURE BEGAN TO DROP. THE PERFUSIONIST ELECTED TO REMOVE THE PUMP HEAD FROM THE MOTOR AND PLACE IN THE MANUAL DRIVE UNIT. THE PERFUSIONIST HAND CRANKED THE PUMP HEAD FOR 10 MINUTES (SYSTEM-1 LOGS VERIFY NO CENTRIFUGAL ACTIVITY FROM 1122 - 1132), AND THE PERFUSION PRESSURE WAS MAINTAINED AT 25-35 MMHG. THE SYSTEM-1 PERFUSION SCREEN WAS EXITED AND RE-BOOTED, AND THE PUMP HEAD WAS PLACED BACK IN THE MOTOR. CPB WAS COMPLETED WITH THE MOTOR AND SYSTEM-1 PROVIDING ARTERIAL BLOOD FLOW. THERE WERE NO FUNCTIONAL ISSUES SEEN WITH THE PUMP HEAD ITSELF. THE CASE WAS COMPLETED, AS SCHEDULED, AND THERE WAS NO LOSS OF BLOOD ASSOCIATED WITH THIS EVENT. THE PT WAS DIAGNOSED WITH A STROKE AFTER THE PROCEDURE. THE PUMP HEAD WAS REVIEWED, BY A TERUMO FIELD SERVICE ASSOCIATED, BY PLACING THE DEVICE ON A MANUAL DRIVE UNIT. THE DEVICE APPEARED TO FUNCTION (IMPELLERS WERE ABLE TO BE ROTATED). A VOLUNTARY MEDWATCH WAS RECEIVED FROM THE USER FACILITY ON (B)(4) 2014 INDICATING THAT THE PT EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54623 SINGLE STERILE X-COATED DELPHIN PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORP 164275X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| R