BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3202078 · Received June 27, 2013

    Report

    Report Number
    1828100-2013-00604
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 15, 2013
    Report Date
    June 6, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWB
    PMA / PMN Number
    K953901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE CASE, THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) TESTED THE PUMP. HE WAS ABLE TO DUPLICATE THE ISSUE. PER BIOMED, WHEN THE MEMBRANE SWITCH WAS TAPPED LIGHTLY, THE PUMP STOPS. THIS ROLLER PUMP WAS TAKEN OUT OF SERVICE AND KEPT IN THE BIOMED SHOP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP STOPPED TURNING THREE TIMES DURING CASE. THE DEVICE WAS NOT CHANGED OUT, AS THEY WERE ABLE TO GET THE PUMP SPINNING AGAIN BY HITTING THE START BUTTON EACH TIME. THE ROLLER PUMP WAS BEING USED AS A VENT OR SUCKER PUMP. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT. PER THE CLINICAL REVIEW ON (B)(4) 2013: THE PERFUSIONIST (CCP) STATED THE ROLLER PUMP WAS BEING USED AS A VENT PUMP. ON THREE OCCASIONS DURING CPB, THE PUMP WOULD STOP AND ENTER THE "STOP" MODE. THE PUMP COULD BE RE-STARTED WITHOUT DIFFICULTY ON ALL THREE OCCASIONS. AFTER THE CASE, THE PUMP WAS REMOVED FROM THE BASE AND REPLACED WITH A BACK-UP. THE USER BIOMEDICAL ENGINEER NOTICED THE MEMBRANE STOP SWITCH WAS VERY SENSITIVE AND VERY LIGHT TAPPING WOULD PLACE THE PUMP IN THE STOP MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293143 TERUMO PERFUSION SYSTEM 8000 DWB TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1