BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11024844 · Received December 16, 2020

    Report

    Report Number
    2016493-2020-69076
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    June 14, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE DESCRIPTION: BIOMED GETTING A 5-13-1304 ERROR ON A 8110 DURING PM. SN: (B)(4). FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8110 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: RECOMMEND TO REFLASH THE SOFTWARE TO SEE IF IT WILL CLEAR THE ERROR. BIOMED DOES NOT HAVE THE POINT OF CARE SOFTWARE AND THEIR CURRENT VERSION OF V9.12.40 IS END OF LIFE. EMAILED A COPY OF ALARIS SERVICE DESCRIPTION DEPOT REPAIR PRICING. BIOMED WILL GET A PO AND CALL BACK FOR A RMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484283 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1