BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2933216 · Received January 14, 2013

    Report

    Report Number
    1828100-2013-00004
    Event Type
    Other
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS, BUT NOT YET COMPLETED. AFTER THE CASE WAS COMPLETE, THE USERS WENT BACK TO LOOK AT THE SYSTEM LOGS AND FOUND THE CALIBRATION FAILED VERY QUICKLY. THEY READ THE MESSAGE: "CALIBRATION NOT COMPLETE, MANUAL CONTROLS ONLY". THE PERFUSIONIST BELIEVED THAT SHE HAD CALIBRATED THE EPGS AS SHE DID TOUCH THE "CALIBRATE" BUTTON TO INITIATE THE GAS CALIBRATION. SHE WAS NOT AWARE THAT THIS FAILURE MODE REQUIRED A RE-ATTEMPT OF CALIBRATION OR REQUIRED THE USAGE OF THE MANUAL GAS FLOW KNOBS OF THE EPGS MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE PERFUSIONIST NOTICED THE PT'S ARTERIAL BLOOD WAS DARK IN COLOR, THE PT WAS DESATURATED, AND REALIZED THAT THE ELECTRONIC PT GAS SYSTEM (EPGS) HAD NO FLOW GOING TO THE OXYGENATOR. THE PERFUSIONIST USED THE MANUAL GAS FLOW KNOB OF THE EPGS MODULE AND DID NOT SEE ANY RESPONSE ON THE CLIP ON GAS FLOW METER (NO GAS FLOW). SHE MOVED THE GAS LINES TO ANOTHER TOWER IN THE OPERATING ROOM AND STILL NO GAS FLOW WAS OBSERVED TO BE EXITING THE EPGS MODULE. THE SURGICAL TEAM ELECTED TO REMOVE THE AORTIC CROSS-CLAMP, FILL THE HEART, AND WEAN THE PT OFF CPB. THE SURGEON MANUALLY MASSAGED THE HEART TO PROVIDE SOME CIRCULATORY SUPPORT OF THE SYSTEMIC AND PULMONARY CIRCULATIONS. ANESTHESIA BEGAN TO VENTILATE IN ORDER TO PROVIDE VENTILATORY SUPPORT OF THE BLOOD THAT WAS BEING PROVIDED TO THE PULMONARY AND SYSTEMIC CIRCULATION VIA CARDIAC MASSAGE. THE PERFUSIONIST ELECTED TO DIRECTLY CONNECT THE GAS LINE OF THE OXYGENATOR TO A REGULATED E-CYLINDER OXYGEN TANK. GAS FLOW WAS ESTABLISHED AND VERIFIED. CARDIOPULMONARY BYPASS WAS RE-INSTITUTED AND THE PROCEDURE WAS ABLE TO BE COMPLETED, AS SCHEDULED. THE DELAY WAS ESTIMATED TO BE FOUR MINUTES, WITH TWO MINUTES OF NO VENTILATORY SUPPORT AND TWO MINUTES OF CARDIAC MESSAGE AND VENTILATION BY ANESTHESIA. THERE WAS NO LOSS OF BLOOD ASSOCIATED WITH THIS INCIDENT. THE PT WAS WEANED FROM CPB WITHOUT ISSUE AND WAS TRANSFERRED TO ICU PER ROUTINE PRACTICE. THE PT WAS AWAKE, ALERT, AND RESPONDING TO COMMANDS WITHIN A FEW HOURS OF SURGERY. THE PT WAS EXTUBATED WELL WITHIN 24 HOURS OF SURGERY. THERE WAS NO HARM OBSERVED DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21121 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention