BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 8722755 · Received June 21, 2019

    Report

    Report Number
    1828100-2019-00323
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 29, 2019
    Report Date
    January 30, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Removal / Correction Number
    1828211-10/14/2011-020-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED BLOCKS: D10 AND H3. H3: 81 EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE PREVIOUSLY SUBMITTED MEDWATCH WHERE IT REFERENCED A RECALL IN BLOCK H9. ADDITIONAL CONSIDERATION HAS DETERMINED THAT THE RECALL IS NOT APPLICABLE FOR THIS REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    UPDATED BLOCKS: H3 AND H6. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED THERE TO BE NO ISSUES WITH BOOTING UP THE CENTRAL CONTROL MONITOR (CCM). THE CCM AND THE END USERS NETWORK INTERFACE CARD (NIC) BOARD EVALUATION REVEALED NO SIGNS OF INTERNAL NOR EXTERNAL DAMAGE, INGRESS, OR TAMPERING AND FUNCTIONAL PROPERLY THROUGHOUT ENVIRONMENTAL, CABLE AGITATION, TOUCH SCREEN FUNCTIONALITY AND POWER CYCLING TESTING. PER DATA LOG ANALYSIS, ONLY THE LOCAL AREA NETWORK / INTERFACE BOARD (LAN/IF) LOG WAS PROVIDED. THE LAN I/F DOES NOT CONFIRM THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE SERVICE REPAIR TECHNICIAN (SRT) WAS NOT ABLE TO DUPLICATE THE REPORTED COMPLAINT. THE CENTRAL CONTROL MONITOR (CCM) OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    PER THE PERFUSIONIST, WHEN THE CCM WAS OUT, THE PUMPS WERE UNAFFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) BLACKED OUT SUDDENLY AND RESTARTED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517364 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816300

    Patients

    Seq Age Sex Outcome Treatment
    1