BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3813183 · Received March 26, 2014

    Report

    Report Number
    1828100-2014-00211
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 22, 2014
    Report Date
    March 3, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Removal / Correction Number
    1828100-03/27/12-006-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO OBSOLETE PARTS, THIS UNIT WILL NOT BE REPAIRED. THIS PRODUCT IS BEING PHASED OUT IN THE GLOBAL MARKET. SERVICE AND REPLACEMENT PARTS ARE NO LONGER AVAILABLE. 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 AFTER COMPLETING THE NOTICE OF FIELD CORRECTION (NFC) FOR NETWORK INTERFACE CARD (NIC) POWER CABLES REPLACEMENT PROCEDURE, WHEN WE TURN ON THE CENTRAL CONTROL MONITOR (CCM) TOUCH SCREEN ALIGNMENT WAS MALFUNCTIONING. CUSTOMER TRIED TO CALIBRATE THE TOUCH SCREEN AND RESEATED ALL CABLES BUT FAILED DUE TO TOUCH SCREEN MALFUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176864 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CCM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1