BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 20156577 · Received September 6, 2024

    Report

    Report Number
    1828100-2024-00247
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 13, 2024
    Report Date
    December 3, 2024
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS NOT VERIFIABLE SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION OR TESTING. MULTIPLE DILIGENCE ATTEMPTS FOR PART RETURN WERE UNSUCCESSFUL. 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

    THE DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELLING EFFECTIVENESS DATE, AND THEREFORE DOES NOT CONTAIN A UDI LABEL, BUT THE APPLICABLE UDI INFORMATION ASSOCIATED WITH THE DEVICE IS (01)00886799001363(11)140501(21)6352. PER THE MANUFACTURER'S SUBSIDIARY THE ROLLER PUMP WAS INSPECTED, AND IT WAS FOUND THAT THE OPTICAL ENCODER WAS DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE ROLLER PUMP SPEED COULD NOT BE CONTROLLED WITH THE KNOB. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 30 MINUTE DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887789 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown