BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21580599 · Received March 12, 2025

    Report

    Report Number
    2016493-2025-65323
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    December 26, 2024
    Report Date
    February 20, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811043
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. INVESTIGATION SUMMARY : THE REPORTED COMPLAINT THAT THE SYRINGE MODULE DID NOT ACCEPT THE MEDICATION WAS CONFIRMED THROUGH THE HL7 FILE PROVIDED BY THE FACILITY. EXTERNAL AND INTERNAL INSPECTION COULD NOT BE PERFORMED, SINCE NO DEVICES WERE RETURNED FOR THIS INVESTIGATION. THE HL7 FILE WAS PROVIDED BY THE FACILITY TO INVESTIGATE PROGRAMMING DETAILS. ACCORDING TO A HL7 FILE REVIEWED BY INTEROPERABILITY CONSULTANTS ON (B)(6) 2024 AT 3:20:50 PM THE SUSPECT SYRINGE MODULE S/N (B)(6) WAS ATTACHED TO THE CONCOMITANT PCU S/N (B)(6), AT 3:24:15 PM A FLUCONAZOLE INFUSION WITH 5.37 MG WAS ATTEMPTED TO BE INFUSED AS A SECONDARY, THE FLUCONAZOLE WAS PROGRAMMED MANUALLY AT 15:25:39 MATCHING THE ORDER DETAILS FROM ORDER PREVIOUSLY SENT TO THE PUMP AND SENDING A 9010 ERROR MESSAGE (UNABLE TO MATCH MEDICATION TO DRUG LIBRARY). REVIEW OF THE DATASET SHOWED THE FLUCONAZOLE IS ONLY AVAILABLE TO BE SENT AS A PRIMARY INFUSION, CAUSING THE 9010 ERROR MESSAGE DUE TO THE SELECTION OF A SECONDARY INFUSION INSTEAD OF PRIMARY. PER BD ALARIS SYSTEM USER MANUAL (V12.3), PROPER OPERATION OF THE BD ALARIS¿ SYSTEM REQUIRES THAT YOU ARE FAMILIAR WITH RELATED FEATURES, SETUP, PROGRAMMING, IV SETS, AND ACCESSORIES. READ ALL INSTRUCTIONS, INCLUDING THOSE FOR ALL ATTACHED MODULE(S) AND ASSOCIATED DISPOSABLES BEFORE USING THE BD ALARIS ¿ SYSTEM. IF THE INFUSION ORDER DOES NOT SPECIFY WHETHER THE INFUSION IS TO BE PRE-POPULATED AS A PRIMARY OR SECONDARY INFUSION, THE SYSTEM WILL DETERMINE WHETHER TO PRE-POPULATE THE INFUSION AS PRIMARY OR SECONDARY BASED ON THE STATE OF THE INTENDED MODULE AND ON THE GUARDRAILS DRUG LIBRARY CONFIGURATION. THE FOLLOWING SECONDARY INFUSIONS CAN BE PRE-POPULATED (PUMP MODULE ONLY): INTERMITTENT. ACCORDING TO ALARIS SYSTEM USER MANUAL IF A PUMP MODULE IS ATTACHED, A PRI/SEC VOLUME SOFT KEY IS AVAILABLE TO ALLOW SECONDARY VOLUME INFUSED TO BE DISPLAYED. THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORT THAT THE SYRINGE MODULE DID NOT ACCEPT THE MEDICATION WAS ATTRIBUTED TO USER ERROR. ACCORDING TO A REVIEW OF THE HL7 FILE AND THE DATASET, FLUCONAZOLE IS ONLY AVAILABLE TO BE SENT AS A PRIMARY INFUSION. IN EPIC, THE CLINICIAN HAS THE CHOICE OF CHOOSING PRIMARY OR SECONDARY. IF THE CLINICIAN INADVERTENTLY CHOSE SECONDARY INSTEAD OF PRIMARY, THIS WOULD HAVE BEEN REJECTED BY THE BD ALARIS SYSTEM, CAUSING THE 9010-ERROR MESSAGE TO BE SENT FROM EPIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NICU NURSE SCANNED FLUCONAZOLE ON (B)(6) 2024 15:54 AND THE PUMP WOULD NOT ACCEPT THE MEDICATION. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN HARM. ADDITIONAL INFORMATION RECEIVED: PER EMAIL "THERE WAS NO PATIENT HARM. THE FLUCONAZOLE WAS ATTEMPTED TO BE INFUSED AS A SECONDARY INFUSION; HOWEVER, THE INFUSION CAN ONLY BE SENT (EPIC) AS A PRIMARY VIA THE SYRINGE MODULE. CHOOSING THE SECONDARY INSTEAD OF PRIMARY WOULD HAVE BEEN REJECTED BY THE BD ALARIS SYSTEM CAUSING THE 9010 ERROR MESSAGE. THE FLUCONAZOLE WAS PROGRAMMED MANUALLY ON (B)(6) 2024 AT 15:25:39.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148542 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown