BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20123028 · Received September 3, 2024

    Report

    Report Number
    2016493-2024-35109
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    June 25, 2024
    Report Date
    October 17, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION 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.

    Additional Manufacturer Narrative · 0

    OMIT : B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. THE COMPLAINT OF THE PUMP MODULE FAILING TO ALARM FOR AIR IN LINE WAS NOT CONFIRMED DURING LOG REVIEW OR REPRODUCED DURING TESTING. LABORATORY TESTING PERFORMED ON THE SOURCE PUMP MODULE¿S AIR IN LINE DETECTION SYSTEM FOUND THE DEVICE WAS DETECTING AIR FOR BOTH SINGLE AIR BOLUS AND ACCUMULATED AIR BOLUS WITHIN SPECIFICATION. EXTERNAL AND INTERNAL INSPECTION PROCESS WAS PERFORMED ON THE PUMP MODULE, THERE WERE NO ISSUES OR ANOMALIES IDENTIFIED DURING THE INSPECTION OF THE SUSPECT DEVICE. PCU EVENT LOG HAD BEEN OVERWRITTEN EVENTS FROM 25 JUNE 2024 COULD NOT BE REVIEWED. THE PUMP MODULE EVENT LOG RECORDED THE PUMP MODULE WAS SELECTED ON 25 JUNE 2024 AND PROGRAMMED TO INFUSE AN UNKNOWN MEDICATION AT A RATE OF 633ML/HR. A SINGLE AIR BOLUS LIMIT WAS SET TO 250¿L WITH ACCUMULATED AIR DETECTION ENABLED. REVIEW OF THE PCU AND PUMP MODULE ERROR LOGS SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. THERE ARE MULTIPLE SMALLER SINGLE AIR BOLUS SETTINGS (50 ¿L, 75 ¿L, 125 ¿L, 175 ¿L, 250 ¿L) AVAILABLE TO THE CUSTOMER, IF MORE SENSITIVITY IS DESIRED IN AIR IN LINE DETECTION. HOWEVER, THE PROFILE GUARDRAILS MAY OVERRIDE INDIVIDUAL SYSTEM CONFIGURATION SETTINGS. THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE PROBABLE CAUSE OF THE PUMP MODULE FAILING TO ALARM FOR AIR IN LINE IS SUSPECTED TO BE DUE TO SINGLE AIR BOLUSES BEING TOO SMALL TO TRIGGER AT THE 250UL SETTING. LABORATORY TESTING SHOWED THE AIL WAS DETECTING AIR AS EXPECTED. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A1801, G04037, C0601, D15 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DEXTROSE 5% WATER FLUSH INFUSING AT 633ML/HR THE PUMP MODULE DID NOT DETECT "AIR-IN-LINE". THIS WAS CAUGHT PRIOR TO REACHING THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DEXTROSE 5% WATER FLUSH INFUSING AT 633ML/HR THE PUMP MODULE DID NOT DETECT "AIR-IN-LINE". THIS WAS CAUGHT PRIOR TO REACHING THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186499 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015.