BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20209394 · Received September 13, 2024

    Report

    Report Number
    2016493-2024-36142
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 15, 2024
    Report Date
    November 12, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT : C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION: IMDRF ANNEX A, B, C, D, G CODES AND MANUFACTURER NARRATIVE. THE ACTUAL DATE OF EVENT IS UNKNOWN. INVESTIGATION SUMMARY: THE REPORTED COMPLAINT OF PATIENT-SIDE OCCLUSION WAS NOT CONFIRMED WITH THE INFORMATION VIA EMAIL AND NO DEVICES WERE RETURNED FOR INVESTIGATION. LABORATORY TESTING OF THE DEVICES SUSPECT PUMP MODULE AND CONCOMITANT PCU COULD NOT BE PERFORMED AS INCIDENT DEVICES WERE NOT RECEIVED FOR THIS INVESTIGATION. A LOG ANALYSIS COULD NOT BE PERFORMED AS THERE WERE NO DEVICES OR LOGS RETURNED FOR INVESTIGATION. INSPECTION COULD NOT BE PERFORMED AS THE INCIDENT DEVICE OR ADMINISTRATION SET WERE NOT RETURNED FOR INVESTIGATION. THE ALARIS SYSTEM USER MANUAL V12.3.1 NOTES THAT 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) BEFORE USING THE BD ALARIS¿ SYSTEM. DISCARD INFUSION SET IF PACKAGING IS NOT INTACT, OR PROTECTOR CAPS ARE UNATTACHED. ALSO, THE ALARIS SYSTEM USER MANUAL V12.3.1 NOTES THAR 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. USE ONLY BD ALARIS¿ PUMP INFUSION SETS WITH THE PUMP MODULE. THE USE OF ANY OTHER SET CAN CAUSE IMPROPER DEVICE OPERATION, RESULTING IN AN INACCURATE FLUID DELIVERY OR OTHER POTENTIAL. THE ALARIS PUMP MODULE, MODEL 8100 PRESSURE SENSORS TIP SHEET STATES TO AVOID PRESSURE SENSOR DAMAGE, DO NOT APPLY PRESSURE TO THE CENTER OF THE PRESSURE SENSOR. THE DEVICE WAS REPORTED WITH PATIENT INVOLVEMENT BUT NO HARM. THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR.820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED DEVICES HAD PATIENT-SIDE OCCLUSION, WAS NOT DETERMINED AS NO DEVICES WERE RETURNED FOR THE INVESTIGATION.

    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 THAT THAT THE DEVICE ALARMED PATIENT-SIDE OCCLUSION DURING AN INFUSION OF OXYTOCIN. PER REPORT, ¿OVER A DOZEN DIFFERENT PUMPS WERE USED AND ALL RESULTING OCCLUSION ALARM¿. THE CUSTOMER STATED THAT THE FLOW RATES WERE BETWEEN 2 TO 6ML/HR., AND THE USER HAS TO INCREASE THE RATE TO ¿ABOVE 6ML/HR. TO PREVENT ALARMING¿. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHICH STATES "ONCE THE RATE IS ABOVE 10ML/HR THE ALARMS GO AWAY. THIS HAPPENS SHORTLY AFTER INITIATION OF THE MEDICATION INFUSION." THE CUSTOMER USES BD IV CATHETER (REF 2426-0007), TYPICALLY 18 G, ATTACHED TO THE VELANOVASCULAR EXT STABILIZED EXTENSION SET. THE MAIN LINE (LACTATED RINGERS- THE TYPICAL RATE OF 125-150 ML/HOUR) IS CONNECTED TO THE PORT FURTHEST FROM THE PATIENT FOR SAFETY REASONS. OXYTOCIN IS PUT ON A SEPARATE CHANNEL WITH ITS OWN LINE, ATTACHED TO THE PORT CLOSE TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE DEVICE ALARMED PATIENT-SIDE OCCLUSION DURING AN INFUSION OF OXYTOCIN. PER REPORT, ¿OVER A DOZEN DIFFERENT PUMPS WERE USED AND ALL RESULTING OCCLUSION ALARM¿. THE CUSTOMER STATED THAT THE FLOW RATES WERE BETWEEN 2 TO 6ML/HR., AND THE USER HAS TO INCREASE THE RATE TO ¿ABOVE 6ML/HR. TO PREVENT ALARMING¿. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112652 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown