BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3842916 · Received March 13, 2014

    Report

    Report Number
    1828100-2014-00159
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Removal / Correction Number
    1828100-10/14/11-020-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2013-01014. DURING THE LABORATORY ANALYSIS TO DETERMINE THE PROPER OPERATION OF THE CCM, MDR #1828100-2013-01014, THIS COMPLAINT ISSUE WAS DISCOVERED. THE CCM ISSUED A "SYSTEM COMPUTER NEEDS SERVICE" ERROR MESSAGE. THIS EFFECT WAS NOT WITNESSED BY THE CUSTOMER, BUT WAS OBSERVED DURING MANUFACTURER LABORATORY ANALYSIS. THE ISSUE WAS ISOLATED TO THE PERIPHERAL COMPONENT INTERCONNECT (PCI) CABLE. MECHANICAL AGITATION OF THE CABLE HAD NO EFFECT, BUT REMOVAL/REPLACEMENT OF THE CABLE RESTORED THE CCM TO PROPER FUNCTIONALITY. THE CABLE WAS FOUND TO CAUSE THE DEVICE TO MALFUNCTION AND NO DAMAGE OR OTHER EFFECTS WERE NOTED ON THE CABLE.

    Description of Event or Problem · 1

    THE PRODUCT SURVEILLANCE TECHNICIAN REPORTED THAT DURING LABORATORY EVALUATION CONTROL MONITOR (CCM), IT DISPLAYED A "SYSTEM COMPUTER NEEDS SERVICE" ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150227 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1(CCM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1