BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 10872499 · Received November 19, 2020

    Report

    Report Number
    2016493-2020-44502
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Report Date
    August 9, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1361-2020
    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 TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). (B)(6) NEED ASSISTANCE FOR 8110 S/N (B)(4), THIS A RENTAL DEVICE FROM UHS, THEY ARE TRYING TO TEST A SYRINGE AND POSSIBLY WANT TO PURCHASE SOME SYRINGES DOWN THE ROAD. WHEN (B)(6) UPGRADED THE DEVICES TO THE CORRECT VERSION. HE STARTED SEEING AN ERROR CODE 13-3033-149. I TOLD (B)(6) THAT THIS ERROR CODE REQUIRES A CALIBRATION TEST FOR 8110. UNFORTUNATELY, HE CANNOT RUN THE CALIBRATION TEST BECAUSE HE DOES NOT HAVE THE CALIBRATION KIT IN HIS CURRENT FACILITY. HE NEED TO BORROW THAT CALIBRATION KIT FROM ANOTHER FACILITY. I SUGGESTED TO (B)(6), WHEN HE IS READY TO RUN THE CALIBRATION TEST, HE CAN ALWAYS GIVE US (TECHNICAL SUPPORT) FOR FURTHER ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337294 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1