BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24518160 · Received March 5, 2026

    Report

    Report Number
    2016493-2026-11500
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 18, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX B: B21, ANNEX C: C21, ANNEX D: D16. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER? AND MANUFACTURER NARRATIVE ANNEX A: A1006, A0401, A09, A1801, A040502, A070504, ANNEX B: B01, ANNEX C: C11, C02, C1604, C0503, ANNEX D: D0302, D02, D08, D15, ANNEX G: G02017, G02035, G02002. 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. INVESTIGATION SUMMARY: THE REPORTED ¿BURNING SMELL¿ EVENT IS ATTRIBUTED TO BURNED PINS ON THE FEMALE IUI CONNECTOR. THE LIKELY CAUSE OF THE CONNECTOR HOUSING MELT DAMAGE, AND THE ASSOCIATED ERROR CODES ARE A THERMAL EVENT RESULTING FROM A SHORT CIRCUIT, TRIGGERED BY LIQUID ACCUMULATION, CONTAMINATION, RESIDUE BUILDUP, AND/OR CORROSION BRIDGING THE IUI PINS. THE PRECISE COMPOSITION OR ORIGIN OF THE RESIDUE COULD NOT BE DETERMINED. THE LEFT SUSPECT PCU IUI CONNECTOR WAS REMOVED TO CONDUCT A RESISTANCE TEST ON ADJACENT PINS TO DETERMINE IF A SHORT WAS PRESENT. AN INTERNAL AND EXTERNAL INSPECTION OF THE PCU WAS PERFORMED, AND IT WAS OBSERVED THAT SOME PINS OF THE FEMALE IUI CONNECTOR WERE BURNED. A DIGITAL MULTIMETER (C15-3066) WAS USED TO MEASURE RESISTANCE ON EACH PIN. WHEN MEASURING BETWEEN ADJACENT PINS OF THE CONNECTOR, AN INFINITE OHM VALUE (OPEN CIRCUIT) WAS EXPECTED DURING TESTING. EVERY ADJACENT PIN MEASURED INFINITE RESISTANCE, INDICATING THAT THERE WAS NO SHORT CIRCUIT PRESENT. THE SUSPECT PCU S/N (B)(6) PASSED ALL THE PM (PREVENTIVE MAINTENANCE) TESTS IN ALARIS SYSTEM MAINTENANCE (ASM) (V12.5). FUNCTIONAL TESTING WAS PERFORMED ON THE SUSPECT PCU, AND NO PROBLEMS OR ANOMALIES WERE FOUND RELATED TO THE REPORTED EVENT. BETWEEN JANUARY 8 AND JANUARY 27, 2026, THE PCU S/N (B)(6) REGISTERED MULTIPLE MALFUNCTION EVENTS RELATED TO POWER AND AUDIO FAILURES. ON JANUARY 8 AT 5:53 PM, A LOW BACKUP VOLTAGE FAILURE (ERROR CODE 120.4410.0) WAS RECORDED. ON JANUARY 27 BETWEEN 5:26 PM AND 5:29 PM, ADDITIONAL MALFUNCTIONS OCCURRED, INCLUDING ANOTHER LOW BACKUP VOLTAGE FAILURE (120.4410.0), TWO OCCURRENCES OF MAIN SPEAKER FAILURE (133.6090.0), AND FOUR OCCURRENCES OF LOW 8V FAILURE (120.4370.5). EARLIER THAT DAY, AT 4:17 PM, AN INFUSION WAS PROGRAMMED ON PUMP MODULE SN (B)(6) WITH A RATE OF 495.9 ML/H AND A VTBI OF 1000 ML; THE PUMP MODULE WAS REMOVED AT 5:26 PM AFTER DELIVERING A PVI OF 446.09 ML. THE SYSTEM ERROR TIP SHEET NOTES THAT THE BD ALARIS¿ PC UNIT (PCU) SOFTWARE RUNS SELF-CHECKING PROGRAMS PRIOR TO AND DURING OPERATION. A SYSTEM ERROR MESSAGE MEANS THAT THE BD ALARIS¿ SYSTEM HAS IDENTIFIED AN ERROR IN EITHER THE HARDWARE OR THE SOFTWARE OF THE PCU. OBTAIN A NEW PCU. DO NOT POWER DOWN UNTIL A NEW PCU IS AVAILABLE. TAG THE AFFECTED PCU, DESCRIBE THE ERROR AND RETURN IT TO YOUR FACILITY¿S CLINICAL ENGINEERING OR BIOMED DEPARTMENT. THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING 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.

    Additional Manufacturer Narrative · 0

    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 WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD BURNING SMELL, SYSTEM ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD BURNING SMELL, SYSTEM ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583967 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown