BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 11918611 · Received June 2, 2021

    Report

    Report Number
    2016493-2021-53510
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 22, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE CHR, DHR, SHR UPDATED, IMDRF ANNEX A,B,C,D AND G GRID UPDATED. OMIT : A140502 - FREE OR UNRESTRICTED FLOW (2945), B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR SN (B)(6) 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 28JUL2016. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 16JUL2021. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) 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 FOR SN (B)(6) WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEPRIN BOLUS WAS DISPENSED WITHOUT BEING PROGRAMMED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Additional Manufacturer Narrative · 1

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEPRIN BOLUS WAS DISPENSED WITHOUT BEING PROGRAMMED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816960 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 8015