BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23152602 · Received September 26, 2025

    Report

    Report Number
    2016493-2025-117925
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    June 25, 2025
    Report Date
    November 20, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2718-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. 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

    OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, B, C, D, G CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # AND MANUFACTURER NARRATIVE. 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 REPORT OF A CHANNEL ERROR WAS CONFIRMED. LABORATORY TESTING FOUND THE DEVICE WITH A DEFECTIVE BOTTLE SIDE PRESSURE SENSOR. INTERNAL INSPECTION FOUND THE BOTTLE SIDE PRESSURE SENSOR DATE CODE AS FEB2019, MAKING IT 6 YEARS OLD. THE SUSPECT PUMP MODULE WAS SET FOR A TEST INFUSION (RATE OF 500 ML/HR, VOLUME TO BE INFUSED (VTBI) OF 1000 ML). THE TEST FINISHED WITHOUT ALARMING FOR PATIENT SIDE OR BOTTLE SIDE OCCLUSION. VOLTAGES FOR THE BOTTLE SIDE PRESSURE SENSOR WERE OUTSIDE SPECIFICATION, GETTING STUCK AT A HIGH VOLTAGE WHEN PRESSED AND RELEASED. TESTS RESULTS INDICATED THAT THE SUSPECT PUMP MODULE WAS PERFORMING CORRECTLY AS REQUIRED WITH A DCHU BOTTLE SIDE PRESSURE SENSOR INSTALLED FOR TESTING PURPOSES ONLY. REVIEW OF THE SUSPECT PUMP MODULE ERROR LOG IDENTIFIED A BOTTLE SIDE PRESSURE SENSOR ERROR CODE 240.4150.0 ON THE DAY OF THE REPORTED EVENT. IT WAS OBSERVED THAT MOST ERROR LOG ENTRIES ARE RELATED TO A PRESSURE SENSOR MALFUNCTION. THE REVIEW OF THE CONCOMITANT PCU EVENT LOG SHOWED THAT ON 25JUN2025 AT 9:31 AM, THE CHANNEL ALARMED FOR SAFETY CLAMP OPEN. THE USER PROGRAMMED A NEW INFUSION WITH A RATE OF 50ML/HR AND A VOLUME TO BE INFUSED (VTBI) OF 50ML. AT 9:32 AM, THE USER STARTED THE INFUSION. THE PRIMARY VOLUME INFUSED (PVI) WAS RECORDED AS 37.985ML, AN ACCUMULATED TOTAL FROM PREVIOUS INFUSIONS. AT 9:33 AM, THE DEVICE ALARMED FOR CHANNEL ERROR WITH ERROR CODE 240.4150.0 AND THE USER CHANNELED OFF THE UNIT. THE PVI WAS RECORDED AS 38.485ML. THE PRESSURE SENSOR TIP SHEET STATES THAT TO AVOID PRESSURE SENSOR DAMAGE, DO NOT APPLY PRESSURE TO THE CENTER OF THE PRESSURE SENSORS. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORT OF A CHANNEL ERROR WAS CONFIRMED TO BE A DEFECTIVE BOTTLE SIDE PRESSURE SENSOR. VOLTAGE TESTING SHOWED THE BOTTLE SIDE PRESSURE SENSOR TO GET STUCK IN A HIGH VOLTAGE STATE AFTER RELEASING THE APPLIED FORCE. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A040502, A1801, A0509, C0601, C07, D0302, D15, G02017, G04067, G0405206, G04037, G04088 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LARGE VOLUME PUMP MODULE WAS INVOLVED IN AN INCIDENT WHERE THE PUMP MODULE WAS DISPLAYING A CHANNEL ERROR. THE ERROR LOGS WERE CHECKED AND IT WAS WAS FOUND TO HAVE A BOTTLE SIDE PRESSURE SENSOR FAULT (240.4150.0). THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LARGE VOLUME PUMP MODULE WAS INVOLVED IN AN INCIDENT WHERE THE PUMP MODULE WAS DISPLAYING A CHANNEL ERROR. THE ERROR LOGS WERE CHECKED AND IT WAS WAS FOUND TO HAVE A BOTTLE SIDE PRESSURE SENSOR FAULT (240.4150.0). THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111729 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015