BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3669938 · Received November 20, 2013

    Report

    Report Number
    1828100-2013-01026
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 30, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER EXPRESSED CONCERN ABOUT PLUG OR GROUNDING OF THE PERFUSION SYSTEM. THE SYSTEM WAS TAKEN OUT OF SERVICE AFTER THE CASE WAS COMPLETED. THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT DUPLICATE THE REPORTED COMPLAINT. THE FSR CHECKED THE SYSTEM GROUND, WAS GOOD AND THE LEAKAGE CURRENT WAS GOOD. THE GROUNDS ON THE PERFUSION SYSTEM WERE GOOD ALSO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CUSTOMER FELT A SHOCK WHILE HOLDING A MEDTRONIC TEMPERATURE PROBE. THE DEVICE WAS NOT CHANGED OUT, AS THEY CONTINUED TO USE THE SYSTEM FOR THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT. PER THE CLINICAL REVIEW ON (B)(6) 2013: THE PERFUSIONIST (CCP) WAS USING A MEDTRONIC PERFUSION CIRCUIT WHICH INCLUDED A MEDTRONIC MYOTHERM XP CARDIOPLEGIA KIT. A TEMPERATURE PROBE WAS CONNECTED FROM THE CARDIOPLEGIA KIT TO THE SYSTEM 8000 CARDIOPLEGIA (CPG) MONITOR. DURING SET-UP, THE TEMPERATURE PROBE WAS CONNECTED FROM THE CPG MONITOR TO THE CARDIOPLEGIA KIT. DURING PRIMING AND DEBUBBLING OF THE CARDIOPLEGIA KIT, THE CCP FELT A SHOCK WHEN HE TOUCHED THE PROBE END THAT ATTACHES TO THE CARDIOPLEGIA KIT. THE CCP DESCRIBED THE SHOCK AS SIMILAR TO STATIC ELECTRICITY WHEN YOU RUB YOUR FEET ON CARPET AND TOUCH A METAL OBJECT. THE CCP HAD A CLINICAL PARTNER TOUCH THE PROBE AND SHE ALSO FELT A SHOCK. THE CCP TOUCHED THE PROBE A FEW MINUTES LATER AND DID NOT EXPERIENCE A SHOCK AT THAT TIME. THERE WAS A BACK-UP 8000 AVAILABLE, WITH AN ASSEMBLED PERFUSION CIRCUIT, AND THE CCP ELECTED TO USE THIS BACK-UP CIRCUIT AND 8000 FOR THE PROCEDURE. THE CCP STATED THERE WAS NO DELAY IN THE PROCEDURE, DUE TO ELECTING TO GO TO A BACK-UP SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ASSOCIATED LOSS OF BLOOD AND NO HARM WAS REPORTED TO THE CLINICAL TEAM OR THE PATIENT. THE 8000 WILL NOT BE USED UNTIL CHECK OUT BY A TERUMO FIELD SERVICE REPRESENTATIVE (FSR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603848 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16400

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC PERFUSION CIRCUIT| MEDTRONIC TEMPERATURE PROBE