BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2860773 · Received December 5, 2012

    Report

    Report Number
    1828100-2012-01589
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 20, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE (FSR). THE SERVICE REPAIR TECHNICIAN (SRT) FOUND HEAVY CONTAMINATION CONTRIBUTED TO THE TUBE CLAMP ASSEMBLY NOT BEING ABLE TO BE REMOVED. THE TUBING CLAMP WAS BINDING AND SCREWS WERE FROZEN INTO RACEWAY. THE SRT CONNECTED THE ROLLER PUMP TO A VERIFIED LABORATORY SYSTEM ONE WITH A CENTRAL CONTROL (CCM) CONNECTED AND POWERED ON. THE PUMP OPERATED CORRECTLY WITH THE EXCEPTION OF TH TUBE CLAMP ASSEMBLY. THE CUSTOMER HAS A HISTORY OF IMPROPERLY MAINTAINING THE ROLLER PUMPS AND WAS SENT A LETTER TO REMIND THEM OF THE CLEANING INSTRUCTIONS PROVIDED IN THE OPERATOR'S MANUAL. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE TUBE CLAMP ON THE ROLLER PUMP WOULD NOT COME APART. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 801041

    Patients

    Seq Age Sex Outcome Treatment
    1