BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20234478 · Received September 17, 2024

    Report

    Report Number
    2016493-2024-36359
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 29, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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 REPORT OF AN UNDER INFUSION OF NORMAL SALINE DUE TO INFUSION NOT COMPLETING COULD NOT BE DETERMINED. A LOG ANALYSIS COULD NOT BE PERFORMED AS SUSPECT DEVICES WERE NOT RECEIVED FOR INVESTIGATION. EVENT, ERROR AND BATTERY LOGS FORM THE DEVICES WERE NOT PROVIDED. THE CUSTOMER ONLY PROVIDED THE DATASETS. NO INSPECTION COULD BE PERFORMED AS NO DEVICES WERE RETURNED FOR INVESTIGATION. LABORATORY TESTING COULD NOT BE PERFORMED AS NO DEVICES WERE RETURNED FOR INVESTIGATION. PER THE ALARIS SYSTEM DIRECTIONS FOR USE MANUAL (V12.1) IT STATES: RATE ACCURACY CAN BE AFFECTED BY: TEMPERATURE AND VISCOSITY OF THE IV SOLUTION. HEIGHT OF THE PUMP IN RELATION TO THE PATIENT. HEIGHT OF THE SOLUTION CONTAINER IN RELATION TO THE PUMP. BACK PRESSURE RELATED TO THE INFUSION SET AND THE IV CATHETER. FOLLOW PROPER INFUSION SET LOADING INSTRUCTIONS AND ENSURE THE SET IS FREE OF KINKS AND THAT ALL CLAMPS ARE OPEN BEFORE STARTING AN INFUSION. IMPROPERLY LOADED SETS OR FAILING TO OPEN CLAMPS CAN RESULT IN DELAYED START OF INFUSION OR INACCURATE FLUID DELIVERY (SEE BD ALARIS TM PUMP SET LOADING ON PAGE 87). ENSURE THE UPPER FITMENT IS NOT ELEVATED ABOVE THE FITMENT SECESSION THE PUMP. DO NOT STRETCH OR TWIST THE SET WHILE LOADING OR WHEN CLOSING THE DOOR (SEE BD ALARIS TM PUMP MODULE SET LOADING ON PAGE 87). INSERT UPPER TUBING FITMENT RECESS BEFORE INSTALLING THE SAFETY CLAMP INTO THE LOWER RECESS TO HELP PREVENT STRETCHING OR TWISTING OF THE TUBING DURING LOADING (SEE BD ALARIS TM PUMP MODULE SET LOADING ON PAGE 87). NONE OF THE ABOVE POSSIBLE CAUSES COULD BE INVESTIGATED SINCE IT IS NOT POSSIBLE TO KNOW WHICH IF ANY OF THESE CONDITIONS EXISTED AT THE TIME OF THE FACILITY¿S EVENT. THE DEVICES WERE REPORTED IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF AN UNDER INFUSION OF NORMAL SALINE DUE TO INFUSION NOT COMPLETING COULD NOT BE DETERMINED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN UNDER INFUSION OF NORMAL SALINE. NORMAL SALINE WAS PROGRAMMED TO INFUSE AT A RATE 500ML/HOUR VTBI (VOLUME TO BE INFUSED) PROGRAMMED AT 8:21 AND WENT TO KVO AT 9:21. THE VTBI WAS RESET TO 200ML 9:24 AND AT 10:30 VTBI WAS RESET TO 100ML. NURSE REPORTED THAT THE INFUSION WAS NOT COMPLETING, AND THEY HAD TO KEEP RESETTING THE VTBI. THE EVENT OCCURRED ON 22 AUGUST 2024. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED AN UNDER INFUSION OF NORMAL SALINE. NORMAL SALINE WAS PROGRAMMED TO INFUSE AT A RATE 500ML/HOUR VTBI (VOLUME TO BE INFUSED) PROGRAMMED AT 8:21 AND WENT TO KVO AT 9:21. THE VTBI WAS RESET TO 200ML 9:24 AND AT 10:30 VTBI WAS RESET TO 100ML. NURSE REPORTED THAT THE INFUSION WAS NOT COMPLETING, AND THEY HAD TO KEEP RESETTING THE VTBI. THE EVENT OCCURRED ON (B)(6)2024. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808229 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015.