BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4336530 · Received December 11, 2014

    Report

    Report Number
    1828100-2014-01054
    Event Type
    Death
    Date Received
    December 11, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 20, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CCP TOLD THE FIELD SERVICE REP (FSR) HE DID NOT THINK IT WAS AN ISSUE WITH THE UNIT THAT RESULTED IN THIS PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PATIENT INCURRED MASS HEMOLYSIS WHICH LATER RESULTED IN THE PATIENT EXPIRING. WE ARE NOT AWARE OF ANY DEVICES BEING CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED. PER THE CLINICAL REVIEW ON (B)(6) 2014: THIS HOSPITAL USES A SYSTEM-1 WITH MEDTRONIC DISPOSABLE PRODUCTS. A MEDTRONIC BIOMEDICUS PUMP (BOTH HARDWARE AND DISPOSABLE) IS USED AS THE ARTERIAL PUMP AND THE HARDWARE IS MOUNTED TO THE SYSTEM-1 BUT IS NOT CONNECTED TO SYSTEM-1 SAFETY SYSTEMS. THE MANUFACTURER WAS NOTIFIED THAT THIS PATIENT EXPIRED DURING THE POST-OPERATIVE COURSE. THE CCP WAS NOT A LIBERTY TO PROVIDE ANY DETAILS REGARDING THIS CASE. THE CCP STATED THE HOSP DID SUBMIT A MEDWATCH REPORT TO THE FDA. ACCORDING TO PERFUSIONIST (CCP), THERE WERE SIGNS OF EXCESSIVE HEMOLYSIS (HEMATURIA) DURING AND AFTER CPB. ACCORDING TO THE CCP, ONE OF THE THEORIES BEING CONSIDERED AS A CAUSE OF THE HEMOLYSIS IS A TRANSFUSION REACTION. AS A PRECAUTION, THE HOSP IS EXPLORING OTHER POTENTIAL CAUSES OF EXCESSIVE HEMOLYSIS AND SUCTION IS ONE OF THE AREAS BEING ASSESSED. THE MANUFACTURER BECAME AWARE OF THIS PATIENT DEATH, AS THE CCP, INQUIRED OF WHAT PUMP INFO IS COLLECTED BY THE SYSTEM-1 LOGS. CLINICAL SERVICES TOLD THE CCP, THAT THE ROLLER PUMP FLOW RATES (CALCULATED BASED ON PUMP SPEED AND TUBING SIZE) ARE TRACKED IN THE LOGS AND THIS INFO IS TIME STAMPED. THE CCP IS NOT CERTAIN, AT THIS TIME, IF THE LOGS WILL BE COLLECTED AND ANALYZED, BUT HE DID NOT WANT TO KNOW WHAT INFO IS TRACKED IN THE LOG SYSTEM. THE CCP STATED HE WILL PROVIDE INFO TO RISK MANAGEMENT (OF THE HOSP) AND THEY WILL CONTACT THE MANUFACTURER IF ADDITIONAL SUPPORT IS REQUESTED (IE: COLLECT/ANALYZE LOGS AND/OR INSPECT THE SYSTEM-1 ROLLER PUMPS). ACCORDING TO THE CCP, THERE WERE NO ERROR CODES AND NO ISSUES WITH SETTING OCCLUSION OF THE SUCTION ROLLER PUMP AND/OR OTHER ROLLER PUMPS. THE CCP STATES THAT THERE WERE NO VISIBLE FUNCTIONAL ISSUES WITH THE PUMPS OR ANY OTHER COMPONENTS OF SYSTEM-1 DURING THIS PROCEDURE. THEY SIMPLY WANT TO CONSIDER ALL POTENTIAL CAUSES OF EXCESSIVE HEMOLYSIS DURING THEIR ROOT CAUSE ANALYSIS. THE SURGICAL PROCEDURE WAS COMPLETED, AS SCHEDULED AND WITHOUT DELAY. NO PART OF THE CPB CIRCUIT WAS CHANGED OUT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804287 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MEDTRONIC CENTRIFUGAL PUMP,| OXYGENATOR,| DISPOSABLE TUBING PACKS