BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 8254908 · Received January 16, 2019

    Report

    Report Number
    1828100-2019-00026
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 16, 2018
    Report Date
    March 28, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    0088679900063
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED VIA DATA LOGS. MULTIPLE DILIGENCE ATTEMPTS FOR PART RETURN WERE UNSUCCESSFUL SO NO FURTHER EVALUATION CAN BE COMPLETED. 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

    THE FIELD SERVICE ENGINEER CONNECTED THE SAFETY MODULES TO THE LEFT NIC BOARD AND DISASSEMBLING ALL THE PARTS IN THE BASE AND THEN REINSTALLED EVERYTHING, THE ALARMS WERE ELIMINATED. HE CHANGED THE CONNECTION OF THE TWO PUMPS TO THE LEFT NIC BOARD. PER DATA LOG ANALYSIS, STARTING ON (B)(6) 2018, SEVERAL PUMPS AND MODULES WERE REPORTING "5V SUPPLY VOLTAGE TEST FAILURE" EVENTS. THIS INCLUDES THE FOLLOWING PUMPS/MODULES: LARGE ROLLER PUMP; SMALL ROLLER PUMP; AIR BUBBLE DETECTION; LEVEL SENSOR; PRESSURE MODULE; TEMPERATURE MODULE. MOST LIKELY CAUSE WOULD BE THE POWER CABLE FROM THE POWER MANAGER TO THE NIC. THE NIC OR THE POWER MANAGER COULD ALSO CAUSE THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, TWO ROLLER PUMPS THAT WERE CONNECTED TO THE RIGHT NETWORK INTERFACE CARD (NIC) BOARD HAD A "?" MARK AND WERE CROSSED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: ON (B)(6) 2018, ACCORDING TO THE INFORMATION AVAILABLE, A NOTICE OF FIELD CORRECTION (NFC) WAS PERFORMED AND AFTERWARDS THERE WERE QUESTION MARKS RED X'S ON TWO PUMPS AND THE MODULES THAT WERE ATTACHED TO THE RIGHT NIC BOARD. THE POWER MANAGER AND ALL CONNECTIONS WERE DISASSEMBLED AND ASSEMBLED AGAIN, AND THE ALARMS WERE ELIMINATED. THE FOLLOWING DAY AFTER THE NFC, SAME ALARMS OCCURRED. THE FIELD SERVICE ENGINEER ADDRESSED AND CONNECTED THE SAFETY MODULES TO THE LEFT NIC BOARD, AND DISASSEMBLED ALL THE PARTS IN THE BASE AND REINSTALLED, THEM AND THE ALARMS WERE ELIMINATED. THE TWO PUMPS STILL REMAINED PLUGGED IN THE RIGHT NIC BOARD. THE PUMP WAS THEN USED IN THE CASE ON (B)(6) 2018. BOTH PUMPS, THE CPG PUMP AND THE SUCKER PUMP THAT WERE PLUGGED INTO THE RIGHT NIC BOARD DURING THE PROCEDURE, GAVE THE CLINICIAN RED X'S AND QUESTION MARKS. THE CPG PUMP HAD THE ISSUE AFTER THE LAST DOSE OF THE CPG SOLUTION. THE SUCKER PUMP, THEY WERE ABLE TO USE IT INTERMITTENTLY THROUGHOUT THE CASE. AFTER THE CONCLUSION OF THE PROCEDURE, ALL MODULES AND PUMPS WERE PLACED INTO THE LEFT NIC BOARD. THIS INCIDENT DID NOT DELAY THE CONTINUATION OF THE SURGICAL PROCEDURE. THERE WAS NO BLOOD LOSS OR HARM ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47676 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801764 0088679900063

    Patients

    Seq Age Sex Outcome Treatment
    1