BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14370529 · Received May 12, 2022

    Report

    Report Number
    2016493-2022-139439
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    November 13, 2020
    Report Date
    September 8, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    OMIT : A1407 - INSUFFICIENT FLOW OR UNDER INFUSION (2182). CORRECTION : DATE OF EVENT, DESCRIBE EVENT OR PROBLEM, UNIQUE IDENTIFIER (UDI) #, CONCOMITANT MED PROD DATA, INITIAL REPORTER ADDR 1, INITIAL REPORTER CITY, INITIAL REPORTER ZIP, IMDRF ANNEX A,G CODES. ADDITIONAL INFORMATION: MEDICAL DEVICE SERIAL #, DEVICE MANUFACTURE DATE, IMDRF ANNEX B AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. (B)(4). THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH (B)(6) REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE (B)(6) VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: F05 - DELAY TO TREATMENT/THERAPY. F2301 - ADDITIONAL DEVICE REQUIRED. A090209 - VISUAL PROMPTS WILL NOT CLEAR. A14 - INFUSION OR FLOW PROBLEM. A13 - COMMUNICATION OR TRANSMISSION PROBLEM. E2401 - INSUFFICIENT INFORMATION. THERE WAS PATIENT INVOLVEMENT. A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES, "PATIENT INFUSING AMIODARONE @ 60MG/HR AND PROPOFOL @15MCG/KG/MIN. CHANNELS INFUSING MEDICATIONS WOULD STOP INFUSING WHILE BEEPING ERROR ON CHANNEL. RN SW IN ROOM DURING EVENT, SWITCHED CHANNELS TO ANOTHER PUMP THAT CONTINUED TO HAVE CHANNEL AND COMMUNICATION ERRORS. THE THIRD BRAIN WITH TWO NEW CHANNELS WORKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064090 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015| 8015| 8600| 8600