BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 9488347 · Received December 18, 2019

    Report

    Report Number
    1828100-2019-00665
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 27, 2019
    Report Date
    May 12, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED. 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 · 0

    UPDATED BLOCK: D10.

    Additional Manufacturer Narrative · 0

    PER DATA LOG ANALYSIS, MULTIPLE MODULES/PUMPS ARE REPORTING INTERMITTENT '5 VOLTS (V) SUPPLY VOLTAGE TEST FAILURE' EVENTS WHICH WILL CAUSE A RED X TO APPEAR ON THE MODULE. THIS WILL ALSO CAUSE AN ALARM TO SOUND. THESE ERRORS HAPPENED ON 27-NOV-2019, 02-DEC-2019, AND 04-DEC-2019 WHEN THE LOGS WERE EXPORTED. BELOW IS THE LIST OF MODULES WITH 5V ERRORS. DATA TRANSFER 01395. LARGE ROLLER PUMP 03737. LARGE ROLLER PUMP 03740. LARGE ROLLER PUMP 03747. SMALL ROLLER PUMP 01661. THE 5V SUPPLY CAME FROM THE POWER MANAGER TO THE MODULES/PUMPS THROUGH THE LEFT AND RIGHT NETWORK INTERFACE CONTROLLER (NIC) BOARDS. IF ALL OF THESE MODULES/PUMPS ARE CONNECTED TO THE SAME NIC, THE ISSUE COULD BE THE NIC OR THE POWER CABLE CONNECTING TO IT. THE LOG CONFIRMS THE COMPLAINT. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN OBSERVED THE MEASURED VALUES ACROSS RESISTORS OL K¿, OL K¿ AND OL K¿ TO BE OPEN, LOSING CURRENT. SEVERAL RESISTORS ON THE POWER MANAGER BOARD WERE ALSO FOUND TO BE CHARRED.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) VERIFIED THAT THERE WERE RED XS ON THE UNITS THAT WERE CONNECTED TO THE LEFT SIDE NETWORK INTERFACE CONTROLLER (NIC) PRINTED CIRCUIT BOARD (PCB). HE REPLACED THE POWER MANAGER PCB, LEFT CAN NIC, AND LEFT POWER NIC CABLES. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) INTERMITTENTLY DISPLAYED MULTIPLE RED X'S. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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
    1285978 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801763

    Patients

    Seq Age Sex Outcome Treatment
    1