BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3922160 · Received May 23, 2014

    Report

    Report Number
    1828100-2014-00432
    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, -00385, -00390, -00431, -00433, -00434, -00435 AND 00476. THE SOFTWARE DATA LOG WAS RETURNED TO THE MFR ON (B)(4) 2014 FOR FURTHER EVAL. 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-02228" WAS FOUND. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309184 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1