BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2941518 · Received January 31, 2013

    Report

    Report Number
    1828100-2013-00106
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 9, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP (FSR) REPLACED THE BROKEN LATCH. THE FSR COMPLETED THE PREVENTATIVE MAINTENANCE AND THE UNIT OPERATED TO MFR SPECS AND WAS RETURNED TO CLINICAL USE. THIS MDR IS RELATED TO MDR #1828100-2013-00061. IF ADD'L INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PERFUSIONIST ATTEMPTED TO OPEN THE FRONT PANEL OF THE 8000 BASE TO INSPECT AND POTENTIALLY ACCESS POWER CABLE TO PUMPS AND THE STOP LINES, BUT THE PANEL WAS JAMMED AND COULD NOT BE OPENED, WHILE TROUBLESHOOTING ANOTHER ISSUE. THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) WAS TROUBLESHOOTING THE ISSUE DURING NON-CLINICAL ACTIVITY AND COULD NOT GET THE DOOR OPENED ON THE UNIT. THE BIOMED BROKE THE LATCH OFF WHEN HE PRIED IT OPEN AND THE LATCH WAS NOT SAVE TO BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42227 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16401

    Patients

    Seq Age Sex Outcome Treatment
    1