BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4090067 · Received August 18, 2014

    Report

    Report Number
    1828100-2014-00674
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. SOFTWARE DATA LOGS WERE RECEIVED BY THE MFR ON (B)(4) 2014 FOR FURTHER EVAL. PER TECHNICAL SUPPORT ON (B)(4) 2014, THEY ASKED THE CUSTOMER TO CHECK ALL THE CONNECTIONS, HARD DRIVE POWER CABLE, CABLE THAT CONNECTS THE SINGLE BOARD COMPUTER (SBC) BOARD TO THE LOCAL AREA NETWORK/INTERFACE BOARD (LAN/IF) INTERNAL TO THE CENTRAL CONTROL MONITOR (CCM) AND THE D/C TO D/C POWER SUPPLY CONNECTIONS INTERNAL TO THE CCM. PER EMAIL FROM THE SUBSIDIARY SITE ON (B)(4)2014: OUR SERVICE ENGINEER CONFIRMED THE CCM CABLE WAS SECURELY CONNECTED TO THE BASE WHEN HE REPLACED THE CCM FOR THE CUSTOMER. THEREFORE, WE SUSPECT THAT THE CAUSE COULD BE A BAD CABLE OR BAD CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) SHUT DOWN AND RESTARTED BY ITSELF (TWICE). THEY FOUND AN ERROR MESSAGE ON LOCAL SCREEN. OTHER UNITS LIKE ROLLER PUMP CONTINUED TO WORK. THE PERFUSIONIST (CCP) PLUGGED THE SYSTEM INTO A DIFFERENT OUTLET ON THE WALL AND REBOOTED THE SYSTEM. THE OUTLET ON THE WALL AND REBOOTED THE SYSTEM. THE REPORTED ISSUE DID NOT REOCCUR. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496394 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CCM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1