BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20973793 · Received December 19, 2024

    Report

    Report Number
    2016493-2024-44892
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 6, 2024
    Report Date
    January 10, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION: IMDRF ANNEX A, B, C, D, G CODES AND MANUFACTURER NARRATIVE. OMIT: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. 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 AN OVER INFUSION OF MAGNESIUM-SULFATE WAS NOT CONFIRMED THROUGH A REVIEW OF THE DEVICE LOGS ALONE. INSPECTION AND TESTING OF THE DEVICES COULD NOT BE PERFORMED AS THEY WERE NOT PROVIDED FOR INVESTIGATION. THE CONCOMITANT PCU EVENT LOG SHOWED THAT ON (B)(6) 2024 AT 4:16 PM, THE SYSTEM WAS POWERED ON AND IMMEDIATELY A TIME OF DAY MODIFIED EVENT TURNED THE CLOCK ONE (1) HOUR BACK. AT 3:18, THE DEVICE ALARMED FOR SAFETY CLAMP OPEN FOR 6 SECONDS INDICATING THE ADMINISTRATION SET WAS REINSTALLED. THE USER PROGRAMMED AND STARTED A NEW GUARDRAILS INFUSION OF MAGNESIUM-SULFATE, CONCENTRATION: 2G/50ML, RATE: 25ML/HR AND VOLUME TO BE INFUSED (VTBI): 50ML. THE PRIMARY VOLUME INFUSED (PVI) WAS RECORDED AS 0ML. AT 3:36 PM, THE USER PAUSED THE INFUSION AND POWERED DOWN THE SYSTEM. PVI WAS RECORDED AS 5.755ML. FROM 3:39 PM TO 4:06, THE USER POWERED ON AND OFF THE SYSTEM TWO (2) TIMES WITH NO INFUSIONS PROGRAMMED BUT SELECTED THE CHANNEL A FEW TIMES AND PERFORMED ACTIVITY OF INFUSION ASSESSMENT. IT IS NOT POSSIBLE TO DETERMINE WHAT THE ACTUAL VOLUME IS WITHIN AN IV CONTAINER AT THE START AND ENDING OF AN INFUSION FROM A REVIEW OF THE PCU EVENT LOG. THIS IS NOT A FUNCTION OF THE EVENT LOG; IT ONLY CAN REFLECT THE INPUTTED INFORMATION IT RECEIVES EITHER MANUALLY OR REMOTELY WITH RESPECT TO VOLUME TO BE DELIVERED. THE PCU EVENT LOG COULD NOT DETERMINE WHY THE INFUSION THAT WAS PROGRAMMED TO INFUSE FOR APPROXIMATELY 2 HOURS WAS TERMINATED EARLY AFTER ONLY INFUSING FOR APPROXIMATELY 18 MINUTES. THE BD ALARIS USER MANUAL V12.1.2 (DIR 10000292699) HAS INFORMATION FOR THE USER REGARDING PROGRAMMING. THE USER SHOULD CONFIRM CORRECT PROGRAMMING PRIOR TO STARTING THE INFUSION. ¿TO PREVENT A POTENTIAL FREE-FLOW CONDITION, ENSURE THAT NO EXTRANEOUS OBJECT (FOR EXAMPLE, BEDDING, TUBING, GLOVE) IS ENCLOSED OR CAUGHT IN THE PUMP MODULE DOOR.¿ THE ALARIS SYSTEM USER MANUAL, DOOR KEYPAD ARTWORK, AND THE QUICK REFERENCE GUIDE REMIND THE USER TO ¿CLOSE THE ROLLER CLAMP BEFORE OPENING THE DOOR¿. 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 MAGNESIUM-SULFATE OVER INFUSION WAS NOT ABLE TO BE IDENTIFIED FROM A LOG ONLY INVESTIGATION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 2G IN 50ML MAGNESIUM SULFATE INFUSION WAS MANUALLY PROGRAMMED VIA GUARDRAILS TO INFUSE AT 25ML/HR OVER 2 HOURS. AFTER 30 MINUTES, THE LARGE VOLUME PUMP MODULE BEGAN ALARMING. THE RN WENT TO THE BEDSIDE AND NOTED THAT THE MAGNESIUM BAG WAS EMPTY. IT WAS LATER NOTED THAT THE MAGNESIUM SULFATE WAS STARTED AT 1518 ON (B)(6) 2024. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. PER THE THIRD PARTY'S INVESTIGATION: "WE HAVE COMPLETED OUR INVESTIGATION AND WERE UNABLE TO DUPLICATE THE REPORTED ISSUE. ALL UNITS WERE FOUND TO BE WITHIN MANUFACTURER¿S SPECIFICATIONS FOR ALL PARAMETERS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 2G IN 50ML MAGNESIUM SULFATE INFUSION WAS MANUALLY PROGRAMMED VIA GUARDRAILS TO INFUSE AT 25ML/HR OVER 2 HOURS. AFTER 30 MINUTES, THE LARGE VOLUME PUMP MODULE BEGAN ALARMING. THE RN WENT TO THE BEDSIDE AND NOTED THAT THE MAGNESIUM BAG WAS EMPTY. IT WAS LATER NOTED THAT THE MAGNESIUM SULFATE WAS STARTED AT 1518 ON (B)(6) 2024. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024189 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015