BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24566248 · Received March 11, 2026

    Report

    Report Number
    2016493-2026-12603
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 21, 2026
    Report Date
    March 12, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403516030
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMDRF ANNEX B CODE AND MANUFACTURER NARRATIVE. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THAT THE PCA ALLOWS PCA DELIVERY AFTER LOADING DOSE WHICH WAS NOT IDENTIFIED DURING THE CUSTOMER CALL. THE CASE ESCALATED TO DCHU. HOWEVER, THERE WAS NO SUFFICIENT SAMPLE TO ADDRESS THE ISSUE. 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.

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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.

    Description of Event or Problem · 0

    PCA ALLOWS TOO MUCH LOADING IS 6G PCA DOSE IS 4 AND HAS A LOCKOUT OF 30 MINUTES YET ALLOWS LOADING DOSE THEN PCA TO GO AND THE PATIENT GETS 10G WITH NO DELAY." THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    PCA ALLOWS TOO MUCH LOADING IS 6G PCA DOSE IS 4 AND HAS A LOCKOUT OF 30 MINUTES YET ALLOWS LOADING DOSE THEN PCA TO GO AND THE PATIENT GETS 10G WITH NO DELAY." THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628633 ALARIS SYSTEM PUMP, INFUSION MEA CAREFUSION SD 8120 10885403516030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015| 8015