BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3922184 · Received May 23, 2014

    Report

    Report Number
    1828100-2014-00385
    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

    (B)(4). THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00390. THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00431. THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00432. THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00433. THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00434. THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00435. THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00476. A BACKUP MODULE WAS PROVIDED TO THE CUSTOMER WHILE THE SUBSIDIARY TESTED THE MODULES FOR THREE MONTHS WITH ONLY ONE FAILURE DURING THIS TIME. SINCE NO FURTHER FAILURES WERE NOTED AT THE SUBSIDIARY, THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(6) 2014. SOFTWARE DATA LOGS WERE RETURNED ON (B)(6) 2014 TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SOFTWARE DATA LOG REVIEW, A "POTENTIAL FAILURE ON AN AIR BUBBLE DETECTOR MODULE PA-00952 WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307137 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802110

    Patients

    Seq Age Sex Outcome Treatment
    1