BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21759406 · Received April 3, 2025

    Report

    Report Number
    2016493-2025-70473
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    February 26, 2025
    Report Date
    May 20, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2718-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER? IMDRF ANNEX A, G, B, C, D CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # 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 REPORTED ISSUE OF THE PUMP MODULE FAILURE TO ALARM WAS NOT IDENTIFIED DURING INVESTIGATION. A REVIEW OF THE DEVICE LOGS SHOWED THAT THE AIL BOLUS LIMIT WAS SET TO 250 ¿L AND THE ACCUMULATED AIR WAS ENABLED ON THE INCIDENT DEVICE. THE SUSPECT DEVICE PASSED WORST CASE TESTING FOR SINGLE AIR BOLUS AND ACCUMULATED AIR DETECTION AND ALARMED AS THE DESIGN INTENDED. THE ALARIS SYSTEM USER MANUAL V12.1.3 SAYS THAT IF AN ALARM AIR IN LINE APPEARS IN THE INFUSION, THE RESPONSE OF THE ALARM IS ¿ENSURE THAT THE TUBING IS PROPERLY INSTALLED IN THE AIR-IN-LINE DETECTOR. IF AIR IS PRESENT, CLEAR THE AIR FROM ADMINISTRATION SET PRESS THE RESTART KEY, OR PRESS THE CHANNEL SELECT KEY AND THEN THE START SOFT KEY¿ ADDITIONALLY, THE BD ALARIS PUMP MODULE AIR IN LINE TIP SHEET STATES, WHEN INSERTING THE TUBING INTO THE AIL DETECTOR, USE A FINGERTIP AND FIRMLY PUSH TUBING TOWARD THE BACK OF THE AIL DETECTOR. CLOSE THE ROLLER CLAMP ON THE TUBING SET AND PAUSE THE CHANNEL BEFORE REPLACING A FLUID CONTAINER TO AVOID AIR FROM ENTERING THE IV TUBING ALLOW SOLUTIONS TO WARM TO ROOM TEMPERATURE, IF POSSIBLE. (WHEN INFUSING A CHILLED SOLUTION, AIR BUBBLES MAY FORM AS COLD SOLUTIONS BEGIN TO WARM.) THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820 198(D)(2). NOTES TO REPAIR CENTER: PLEASE RE-TORQUE ALL SCREWS. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING PROCEDURES FOR THE DEVICE, CHECKING FOR ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DESIGNATED COMPLAINT HANDLING UNIT (DCHU) WILL NOT OVER THE COSTS ASSOCIATED WITH ANY INCIDENTAL FINDINGS OR COMPONENTS THAT HAVE BEEN PHYSICALLY ABUSED. ROOT CAUSE: THE ROOT CAUSE FOR THE PUMP MODULE FAILURE TO ALARM WAS NOT CONFIRMED OR REPLICATED DURING INVESTIGATION. THE RETURNED DEVICE WAS EVALUATED TO THE EXTENT OF THE TESTS, AND NO ISSUES OR ANOMALIES WERE OBSERVED DURING THE LOG REVIEW AND LABORATORY TESTING. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A1801, G04017, C0601, D01 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A PATIENT WITH A RED BLOOD CELL TRANSFUSION INFUSING. IT WAS NOTED THAT THE PUMP MODULE DID NOT ALARM THAT AIR WAS IN THE LINE AND THERE WAS APPROXIMATELY 2 FEET OF AIR THAT WENT PAST THE PUMP/CHANNEL. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A PATIENT WITH A RED BLOOD CELL TRANSFUSION INFUSING. IT WAS NOTED THAT THE PUMP MODULE DID NOT ALARM THAT AIR WAS IN THE LINE AND THERE WAS APPROXIMATELY 2 FEET OF AIR THAT WENT PAST THE PUMP/CHANNEL. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654467 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015