BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3692024 · Received March 14, 2014

    Report

    Report Number
    1828100-2014-00158
    Event Type
    Death
    Date Received
    March 14, 2014
    Date of Event
    November 18, 2013
    Report Date
    February 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2013-01165. PER THE PERFUSIONIST, IN REFERENCE TO THIS ISSUE THAT OCCURRED ON (B)(6) 2013: AT THAT TIME, THE INCIDENCE WAS RESOLVED WITHOUT ANY SEVERE IMPLICATIONS AND AT THAT POINT, WE SUSPECTED THAT THERE MIGHT HAVE BEEN A FAULT WITH THE OXYGENATOR AND NOT THE CPB SYSTEM, THAT THERE MIGHT HAVE BEEN A LEAK IN THE OXYGENATOR ITSELF. IT WAS ONLY ON THIS DAY ((B)(6) 2013) THAT WE SUSPECTED THAT THE PROBLEM MIGHT ACTUALLY BE WITH THE CPB SYSTEM (A MECHANICAL PROBLEM). SINCE THERE ARE NO CONCRETE EVIDENCE IN THE DATA LOGS (IN MDR #1828100-2013-01165) POINTING TO A FAULTY CENTRIFUGAL PUMP (MOTOR OR CONTROL MODULE), THE CUSTOMER REQUIRES THEIR PUMP BACK AND SUBSIDIARY SITE WILL THEREFORE NOT BE RETURNING THE UNIT TO THE MANUFACTURER. THIS DECISION WAS MADE AFTER A DISCUSSION BETWEEN THE CUSTOMER, MANUFACTURER AND SUBSIDIARY SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CUSTOMER EXPERIENCED A PROBLEM DURING PUMP, WHERE THE REVOLUTIONS PER MINUTE (RPMS) INCREASED WITH DECREASING FLOW RATES. THEY WERE OFF CARDIOPULMONARY BYPASS FOR TWO MINUTES TO CHECK FOR AORTIC CANNULA PLACEMENT. AFTER THE RETURN TO CARDIOPULMONARY BYPASS AND AFTER THE AORTIC CROSS-CLAMP WAS APPLIED BLOOD FLOWS AND RPM WERE REASONABLE. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW ON (B)(4) 2014: THE CASE SUMMARY NOTES WERE STATED THAT ABOUT 5 MINUTES INTO CPB, THE ARTERIAL FLOW RATE DROPPED FROM 3.5 1/MIN TO ABOUT 2.0 1/MIN WITHOUT ANY CHANGE IN PUMP/MOTOR SPEED. THE CENTRIFUGAL MOTOR SPEED WAS INCREASED TO 3200 RPMS WITH NO CHANGE IN FLOW RATE. THE PERFUSION TEAM TROUBLESHOOTED THE INCIDENT AND CONSIDERED THE POSSIBILITY OF A FAULTY OBSTRUCTION IN THE OXYGENATOR. (B)(4)/ MDR #1828100-2013-00158. THE AORTIC CANNULA WAS CHECKED AND NO OBSTRUCTION COULD BE FOUND. THE TEAM ELECTED TO TERMINATE CPB, TEMPORARILY AND CHECK FOR OBSTRUCTIONS AND/OR SHUNT LINES THAT COULD SHUNT BLOOD AWAY FROM THE PATIENT. THE PATIENT WAS OFF CPB FOR ABOUT TWO MINUTES AN THEN RETURNED TO CPB. AFTER RETURN TO CPB, THE BLOOD FLOW RATE WAS ABLE TO BE PROVIDED AT 3.5-3.8 1/MIN AT A PUMP SPEED OF 2400 RPM. TH AORTIC CROSS-CLAMP WAS APPLIED AND THE PATIENT WAS COOLED TO CONTINUE WITH THE OPERATION. THE PROCEDURE WAS CONTINUED WITHOUT FURTHER ISSUE AND THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO MENTION OF PUMP STOPS OR HAND CRANKING. AFTER WEANING FROM CPB, REMAINING BLOOD IN THE PERFUSION CIRCUIT WAS GRADUALLY TRANSFUSED TO THE PATIENT TO REPLACE BLOOD LOST IN THE SUCKERS. ABOUT THIRTY MINUTES AFTER CPB AND DURING TRANSFUSION, FLOW OBSTRUCTION (LOW FLOW AND HIGH RPM) WAS AGAIN OBSERVED. AT THIS POINT, CPB WAS COMPLETED AND THIS HAD NO IMPACT ON CIRCULATORY SUPPORT. THE PATIENT WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152342 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CENTRIFUGAL DRIVE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164267

    Patients

    Seq Age Sex Outcome Treatment
    1