BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 11862003 · Received May 21, 2021

    Report

    Report Number
    2016493-2021-53014
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 30, 2021
    Report Date
    May 28, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 26FEB2007. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 28MAY2021. 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 AIR SENSOR CHIPPED AND PHY DAMAGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AIR SENSOR CHIPED AND PHY DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760103 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1