BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 10891439 · Received November 24, 2020

    Report

    Report Number
    1828100-2020-00454
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 23, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799000496
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED 'RANDOMLY ALARMING' AUDIBLE ALERT SOUNDS AND THE ALARM MESSAGE 'NOT ATTACHED' WAS DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM). WHEN AGITATING THE CABLE/SENSOR, AN ALARM IS TRIGGERED. NO VISUAL DAMAGE WAS OBSERVED TO CABLE OR SENSOR IN THIS AREA. PER THE DATA LOG ANALYSIS, ON (B)(6) 2020 THE LEVEL REPORTED SEVEN TIMES WHILE THE LEVEL DETECTION WAS ENABLED. THE STATUS FOR THE ALERT PROBE CHANGED FROM COUPLED TO UNCOUPLED, BACK TO COUPLED IN LESS THAN ONE SECOND. THIS WILL CAUSE A 'LEVEL NOT ATTACHED' ALERT. IT IS LIKELY THAT THE UNCOUPLED STATUS CLEARED SO FAST THAT THE CCM WAS NOT NOTIFIED OF WHY THE ALERT OCCURRED. THIS WOULD CAUSE AN ALERT TONE WITHOUT AN INDICATION TO THE USER AS TO WHY THE ALERT OCCURRED AS REPORTED. THE SYSTEM LOG DID NOT GO BACK FAR ENOUGH TO COVER THE ISSUE DATE AND CONFIRM THAT THE CCM WAS NOT NOTIFIED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THIS COMPLAINT IS RELATED TO (B)(4) / MEDWATCH #182810-2020-00377.

    Description of Event or Problem · 1

    THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE RED LEVEL SENSOR ALARM WAS GIVING A 'NOT ATTACHED' MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357301 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 195274 00886799000496

    Patients

    Seq Age Sex Outcome Treatment
    1