BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3922154 · Received May 23, 2014

    Report

    Report Number
    1828100-2014-00431
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDRS 1828100-2013-01150, 1828100-2014-00385, -00390, -00432, -00433, -00434, -00435 AND 00476. PER FURTHER COMMUNICATION WITH SUBSIDIARY, THE MODULES ON THIS SYSTEM BASE CONTINUE TO GIVE INTERMITTENT BOOT UP ISSUES. THE CUSTOMER EITHER RE-BOOTS OR REMOVES / RE-PLUGS THE PARTICULAR MODULE AT SET-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SOFTWARE DATA LOG REVIEW, A "POTENTIAL FAILURE WITH LARGE ROLLER PUMP PA-02222" WAS FOUND. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309183 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1