BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3810017 · Received May 1, 2014

    Report

    Report Number
    1828100-2014-00352
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    March 25, 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
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REACH OUT TO THE RISK MANAGER OF THE USER FACILITY, THAT HAD SENT THE MEDWATCH REPORT TO THE FDA. MANUFACTURER'S CLINICAL SUPPORT CALLED THE RISK MANAGER ON NUMEROUS OCCASIONS. THE RISK MANAGER RETURNED THE CALL LATE AFTERNOON OF (B)(4), 2014 AND INFORMED CLINICAL SUPPORT THAT SHE WOULD NOT PROVIDE ANY DETAILS OF THE VENTS OF THE PROCEDURE ON (B)(4), 2014. THE RISK MANAGER INFORMED ME THAT ALL QUESTIONS AND DISCUSSION SHOULD BE DIRECTED TO THEIR OUTSIDE LEGAL COUNSEL FOR THE HOSPITAL. RECEIVE A RETURN CALL FROM THE USER FACILITY'S LEGAL COUNSEL ON (B)(4), 2014. LEGAL COUNSEL STATED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND NOW AT A LONG TERM CARE FACILITY. SHE STATED THE HOSPITAL IS CONTINUING ROOT CAUSE ANALYSIS OF THE VENTS AND THAT THE SYSTEM-1 AND TERUMO PERFUSION CIRCUIT HAS BEEN SEQUESTERED AND CONTINUES TO BE SEQUESTERED. CLINICAL SUPPORT PLACED A CALL TO THE USER FACILITY'S LEGAL COUNSEL ON (B)(4), 2014 TO REQUEST FURTHER INFORMATION REGARDING THE CLINICAL EVENTS AND DEVICE BEHAVIOUR DURING THIS PROCEDURE. AS OF (B)(4), 2014, THEY HAVE NOT RETURNED MY CALL AND HAS NOT PROVIDED ADDITIONAL INFORMATION. DILIGENCE ATTEMPTS WERE UNSUCCESSFUL. THIS COMPLAINT IS RELATED TO MDR #1124841-2014-00056 (PERFUSION DISPOSABLE PACK).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PATIENT HAD BEEN PLACED BACK ON BYPASS DURING CORONARY ARTERY BYPASS GRAFT (CABG) DUE TO SUDDEN CHANGE IN CARDIAC STATUS. SHORTLY AFTER BYPASS INITIATED, AIR WAS NOTED IN THE ARTERIAL CIRCULATION OF THE PUMP CIRCUIT. SOURCE OF AIR UNKNOWN. BYPASS WAS STOPPED AN PROTOCOLS FOLLOWED IN AN EFFORT TO EVACUATE AIR. BYPASS WAS THEN RE-INITIATED AND PROCEDURES CONTINUED WITH PATIENT SUCCESSFULLY TAKEN OF BYPASS. POST-OP, PATIENT WAS UNABLE TO RESPOND TO COMMANDS AND HAS NO PURPOSEFUL MOVEMENT AT THIS TIME. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAYS OR NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261862 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention EDWARDS LIFESCIENCES VENOUS CANNULA| MEDTRONIC ARTERIAL CANNULA| TERUMO DISPOSABLE TUBING PACK| TERUMO OXYGENATOR