BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23264835 · Received October 10, 2025

    Report

    Report Number
    2016493-2025-121505
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 10, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403519284
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2025-121505 IS A CONCOMITANT. THE DEVICE WAS AFFECTED DUE TO THE ISSUE OBSERVED ON THE SUSPECT DEVICE CAPTURED IN MANUFACTURER REPORT NUMBER 2016493-2025-121504.

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD CONSTANT OCCLUSIONS. THE LEFT SIDE OF THE PCU IS NOT FUNCTIONING ¿ ANY UNIT CONNECTED TO THIS SIDE FAILS TO ESTABLISH A CONNECTION. ADDITIONALLY, DEAD SYRINGE IS NOT CONNECTING AT ALL AND APPEAR TO BE COMPLETELY NON-FUNCTIONAL. THE EVENT LOGS SHOW MULTIPLE INSTANCES OF ¿PUMP PRESSURE MODE¿ FOLLOWED BY ¿OCCLUSION_RETRIES_CHANGED¿ ERRORS. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT. DURING AN ON SITE VISIT THE CUSTOMER PROVIDED ADDITIONAL DETAILS TO A BD CLINICAL CONSULTANT. EVENT OCCURRED ON PEDIATRIC INTENSIVE CARE UNIT "SPOKE WITH THE NURSE WHO TOOK CARE OF THE PATIENT. ON 9/12 4PM DID A LINE CHANGE. ON SATURDAY 9/13 APPROXIMATELY 7AM CHANNEL DISCONNECT ERROR ON THE BRAIN AND SCROLLING ON THE MARQUEE ON C CHANNEL THAT IS PINK TAGGED AND SHUT OFF. THE OTHER MODULES WERE INFUSING (OTHER 3) THE WEEKEND 9/13 ON LT909. NURSE TRIED TO REMOVE AND REATTACH MODULE WITH NO SUCCESS. CHANGED ALL (4 MODULES AND 1 BRAIN) CLINICIAN STATED THAT ¿ EACH CHANNEL WAS TAKEN APART AND THEN RECONNECTED INDIVIDUALLY, BUT IT STILL WAS NOT RECOGNIZED PROVIDED BY NURSING CLINICAL SPECIALIST"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD CONSTANT OCCLUSIONS. THE LEFT SIDE OF THE PCU IS NOT FUNCTIONING ¿ ANY UNIT CONNECTED TO THIS SIDE FAILS TO ESTABLISH A CONNECTION. ADDITIONALLY, DEAD SYRINGE IS NOT CONNECTING AT ALL AND APPEAR TO BE COMPLETELY NON-FUNCTIONAL. THE EVENT LOGS SHOW MULTIPLE INSTANCES OF ¿PUMP PRESSURE MODE¿ FOLLOWED BY ¿OCCLUSION_RETRIES_CHANGED¿ ERRORS. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT. DURING AN ON SITE VISIT THE CUSTOMER PROVIDED ADDITIONAL DETAILS TO A BD CLINICAL CONSULTANT. EVENT OCCURRED ON PEDIATRIC INTENSIVE CARE UNIT "SPOKE WITH THE NURSE WHO TOOK CARE OF THE PATIENT. ON (B)(6) 4PM DID A LINE CHANGE. ON SATURDAY (B)(6) APPROXIMATELY 7AM CHANNEL DISCONNECT ERROR ON THE BRAIN AND SCROLLING ON THE MARQUEE ON C CHANNEL THAT IS PINK TAGGED AND SHUT OFF. THE OTHER MODULES WERE INFUSING (OTHER 3) THE WEEKEND (B)(6) ON LT909. NURSE TRIED TO REMOVE AND REATTACH MODULE WITH NO SUCCESS. CHANGED ALL (4 MODULES AND 1 BRAIN) CLINICIAN STATED THAT ¿EACH CHANNEL WAS TAKEN APART AND THEN RECONNECTED INDIVIDUALLY, BUT IT STILL WAS NOT RECOGNIZED PROVIDED BY NURSING CLINICAL SPECIALIST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304759 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403519284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown