BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 11862103 · Received May 21, 2021

    Report

    Report Number
    2016493-2021-53019
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 21, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION DATE RECEIVED BY MANUFACTURER ADDITIONAL INFORMATION IMDRF ANNEX CODES. IMDRF ANNEX G. IMDRF ANNEX B. IMDRF ANNEX C. MANUFACTURER NARRATIVE THE REPORTED ISSUE THAT THE DEVICE HAD AN ERROR CODE 810.9030 WAS CONFIRMED BY TECH SUPPORT. TECH SUPPORT HAD A WALKTHROUGH WITH THE CUSTOMER AND REVEALED THE FOLLOWING, 1. TECH HAS ERROR CODE 810.9030 ON 8015 BD UNIT 2. WHICH ERROR IS CAUSE BY THE POLO IS NOT ABLE TO BOOT BECAUSE THE APPLICATION ELF FILE HAS INVALID CHECKSUM 3. WILL NEED TO FIRST TRY TO RE-FLASH SOFTWARE IF FAILS NEXT REPLACE IS THE LOGIC BOARD ON UNIT. ISSUE SUMMARY PRODUCT TYPE 8015 VERSIONS AFFECTED ALL SYMPTOMS/SYSTEM EFFECT: ALARIS 8015 ERROR CODE 810.9030 . STEPS TO SOLVE (INTERNAL) SOLUTION/WORKAROUND SUMMARY: TROUBLESHOOTING ERROR CODE 810.9030 WITH AN 8015 SUGGESTED MESSAGING: DO YOU HAVE THE 8015 FIRWARE COMPACT FLASH CARDS? HIGH LEVEL STEPS/PROCEDURE: 1. RE-FLASH 8015 FIRMWARE. 2. REPLACE LOGIC BOARD. 3. RETURN TO FACTORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE HAD AN ERROR CODE 810.9030. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE OF EVENT IS UNKNOWN. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY FOR EVALUATION. THE REPORTED EVENT THAT DEVICE HAD AN ERROR CODE 810.9030 COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME, AND NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE HAD AN ERROR CODE 810.9030. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758174 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1