BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12024859 · Received June 18, 2021

    Report

    Report Number
    2016493-2021-54398
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 27, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(4) WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 07DEC2010. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE (B)(6) 2021. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SERVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A SERVICE FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AGILITI HAD RECEIVED A NOTIFICATION THAT EFZ 5045 (131988641), EEU 8314 (12753840), EEU 8618 (12950167), EEX 8175 (13174997) AND EEX 8903 (13326422) WERE REPORTED TO HAVE BEEN INVOLVED IN AN EQUIPMENT INCIDENT. AND THE UNITS WILL NOT BE RETURNED TO BD. AGILITI WILL PERFORM TESTING OF THESE UNITS. THIS IS JUST A FYI, AND NOTHING FURTHER IS NEEDED. THERE WAS NO INJURY TO THE PATIENT. THE PR HAS BEEN CREATED IN-ORDER TO RECORD THE INCIDENT AND SEND THE PR NUMBER TO AGILITI AS AN ACKNOWLEDGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920040 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1