BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSIN SYSTEM 1

    MDR report key: 4213142 · Received August 4, 2014

    Report

    Report Number
    1828100-2014-00676
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00677. THE FIELD SERVICE REPRESENTATIVE (FSR) HOOKED UP THE PUMP HEADS ON ANOTHER SYSTEM-1 AND THE SOFTWARE UPDATE FAILED. THE FSR TOOK THE SMALL P/C CARD OUT OF ITS JACKET AND USED ANOTHER JACKET AND SOFTWARE UPDATE STILL FAILED. THE FSR COULD NOT DO THE NFC WITH THE NEW SOFTWARE CARD. THE FSR REPLACED THE ROLLER PUMP HEAD WITH A LOANER AND COMPLETED PREVENTATIVE MAINTENANCE. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT ROLLER PUMP WAS RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE REPORTED COMPLAINT WAS CONFIRMED BY LABORATORY EVALUATION. THE QUALITY LABORATORY TECHNICIAN REMOVED OF THE ROLLER PUMP MODULE AND REPLACEMENT WITH A KNOWN GOOD MODULE RESOLVED THE ISSUE. CLOSER INSPECTION FOUND THE GENERIC BOARD WITHIN THE MODULE WOULD NOT ALLOW THE NEW SOFTWARE TO BE DOWNLOADED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING NOTICE OF FIELD CORRECTION (NFC) OF THE DEVICE, THE ROLLER PUMP HEAD WAS DEAD AFTER DOZENS OF ATTEMPTS TO LOAD THE 1.40 SOFTWARE. THE PUMP BOOTED UP BEFORE THE FSR TRIED TO PERFORM THE NFC. SINCE THE EVENT OCCURRED DURING NFC, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455618 TERUMO ADVANCED PERFUSIN SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1