BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18901467 · Received March 14, 2024

    Report

    Report Number
    2016493-2024-19155
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 21, 2024
    Report Date
    March 27, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2717-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    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. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[MMS-20-3991 LVP KEYPAD REPLACEMENT P4. MMS-20-1953 SOFTWARE RECALL V12.1.1. MMS-21-4100 BROKEN BEZEL. MMS-20-3817 LVP KEYPAD REPLACEMENT P2]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[MMS-20-3991 LVP KEYPAD REPLACEMENT P4 MMS-20-1953 SOFTWARE RECALL V12.1.1 MMS-21-4100 BROKEN BEZEL MMS-20-3817 LVP KEYPAD REPLACEMENT P2]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451208 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown