BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20890769 · Received December 10, 2024

    Report

    Report Number
    2016493-2024-44196
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    October 24, 2024
    Report Date
    January 3, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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 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 : C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION : IMDRF ANNEX A, G, B, C, D CODES 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 ROOT CAUSE OF THE REPORTED ISSUE OF INACCURATE DELIVERY, COULD NOT BE DETERMINED DUE TO THE LIMITED INFORMATION AVAILABLE. ¿ TESTING AND INSPECTION COULD NOT BE PERFORMED DUE TO THE SUSPECT PUMP MODULE AND CONCOMITANT DEVICES NOT BEING RETURNED FOR INVESTIGATION. ¿ THE FACILITY PROVIDED AN EVENT DATE OF 24 OCTOBER 2024, AND TIME WAS REPORTED TO BE BETWEEN 2000 TO 2359 (8:00 PM TO 11:59 PM). ¿ PER THE BD ALARIS SYSTEM USER MANUAL V12.1. SECONDARY APPLICATIONS REQUIRE THE USE OF A CHECK VALVE OR CLAMP ON THE PRIMARY IV LINE TO PREVENT BACKFLOW OF SECONDARY MEDICATION INTO THE PRIMARY LINE. ¿ THE SECONDARY INFUSION SET MUST BE PRIMED PRIOR TO BEGINNING THE SECONDARY INFUSION. ¿ THE SECONDARY SOLUTION CONTAINER MUST BE HIGHER THAN THE PRIMARY SOLUTION CONTAINER. ¿ WHEN PROGRAMMING A SECONDARY PIGGYBACK INFUSION, CONFIRM THAT THE PROGRAMMED SECONDARY VTBI MATCHES THE ACTUAL VOLUME OF THE BAG (INCLUDING ANY ADDITIVES OR OVERFILL). THIS ENSURES THE ENTIRE SECONDARY VOLUME INFUSES AT THE CORRECT RATE. ¿ THE CLAMP ON THE SECONDARY INFUSION SET MUST BE OPENED. IF THE CLAMP IS CLOSED, THE FLUID IS DELIVERED FROM THE PRIMARY CONTAINER. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ISSUE OF INACCURATE DELIVERY COULD NOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE "SECONDARY FUNCTION ON IV PUMP STOPPED AND REVERTED BACK TO PRIMARY INFUSION BEFORE SECONDARY MED WAS ADMINISTERED." THERE WAS PATIENT INVOLVEMENT BUT NO HARM. CUSTOMER UPDATES ON THE EVENT AS FOLLOW: "BIOMED WAS ABLE TO WORK WITH HANDLER TO GET THE LVP (#P111804) SENT DOWN TO BIOMED. UNFORTUNATELY, BIOMED WAS ONLY ABLE TO RECEIVE THE LVP AND NOT THE PCU OR CONSUMABLES DOWNLOADED ERROR AND EVENT LOGS, CROSS REFERENCED SN OF PCU FROM LOGS AND TMS TO GET ECN. SENT ECN TO ENGINEER AND PSLS REPORTER FOR PCU TO BE TRACKED DOWN AND SENT TO BIOMED. CLINICAL CONFIRMED THAT PCU IS UNOBTAINABLE AND LOST IN CIRCULATION. REVIEWED ERROR LOGS, MOST RECENT ONES WERE 240.4150.5 (SENSOR_BROKEN_HIGH_FAILURE). NO OTHER EVIDENT FAULTS NOTED FOR NOW. BIOMED WILL CONDUCT TESTS TO SEE HOW PRIMARY AND SECONDARY INFUSION WORKS AND TO TRY TO REPLICATE". THE CUSTOMER LATER ADDED THAT THE MEDICATION IS PIP-TAZO 20ML AND SODIUM CHLORIDE 0.9% 110ML TO BE INFUSED OVER 30 MINUTES. A COPY OF THE HEALTH CANADA REPORT WAS RECEIVED, WHICH STATES, "SECONDARY FUNCTION ON IV PUMP STOPPED AND REVERTED BACK TO PRIMARY INFUSION BEFORE SECONDARY MED WAS ADMINISTERED."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE "SECONDARY FUNCTION ON IV PUMP STOPPED AND REVERTED BACK TO PRIMARY INFUSION BEFORE SECONDARY MED WAS ADMINISTERED." THERE WAS PATIENT INVOLVEMENT BUT NO HARM. CUSTOMER UPDATES ON THE EVENT AS FOLLOW: "BIOMED WAS ABLE TO WORK WITH HANDLER TO GET THE LVP (#P111804) SENT DOWN TO BIOMED. -UNFORTUNATELY, BIOMED WAS ONLY ABLE TO RECEIVE THE LVP AND NOT THE PCU OR CONSUMABLES -DOWNLOADED ERROR AND EVENT LOGS, CROSS REFERENCED SN OF PCU FROM LOGS AND TMS TO GET ECN -SENT ECN TO ENGINEER AND PSLS REPORTER FOR PCU TO BE TRACKED DOWN AND SENT TO BIOMED -CLINICAL CONFIRMED THAT PCU IS UNOBTAINABLE AND LOST IN CIRCULATION -REVIEWED ERROR LOGS, MOST RECENT ONES WERE 240.4150.5 (SENSOR_BROKEN_HIGH_FAILURE) -NO OTHER EVIDENT FAULTS NOTED FOR NOW -BIOMED WILL CONDUCT TESTS TO SEE HOW PRIMARY AND SECONDARY INFUSION WORKS AND TO TRY TO REPLICATE" THE CUSTOMER LATER ADDED THAT THE MEDICATION IS PIP-TAZO 20ML AND SODIUM CHLORIDE 0.9% 110ML TO BE INFUSED OVER 30 MINUTES. A COPY OF THE HEALTH CANADA REPORT WAS RECEIVED, WHICH STATES, "SECONDARY FUNCTION ON IV PUMP STOPPED AND REVERTED BACK TO PRIMARY INFUSION BEFORE SECONDARY MED WAS ADMINISTERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633976 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015