BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 11811792 · Received May 12, 2021

    Report

    Report Number
    2016493-2021-52258
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 19, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION : MANUFACTURER NARRATIVE- CHR, DHR ADDITIONAL INFORMATION : IMDRF ANNEX A,B,C,D AND G GRID, MANUFACTURER NARRATIVE- SHR A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS SERIALIZED DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 28MAR2014. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 19MAY2021. 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 RECORD FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A SERVICE FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ERROR 120-441, AFTER 20 MIN WHILE IT WAS TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE OF EVENT IS UNKNOWN. DEVICE EVALUATED BY BD SERVICE AND NOT RETURNED TO MANUFACTURING FACILITY FOR EVALUATION. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE SN (B)(4) 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 28MAR2014. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 04MAY2021. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ERROR 120-441 ,AFTER 20 MIN WHILE IT WAS TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708240 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1