BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21394795 · Received February 18, 2025

    Report

    Report Number
    2016493-2025-62230
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    September 4, 2024
    Report Date
    January 28, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403516023
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. INVESTIGATION SUMMARY : ALTHOUGH THE REPORT OF A SYSTEM ERROR CODE 133.6090 WAS CONFIRMED DURING LOG REVIEW, THE ERROR WAS NOT REPRODUCED DURING LABORATORY TESTING. ¿ REVIEW OF THE PCU ERROR LOG SHOWED, PRIOR TO THE ISSUE BEING REPORTED, THE REPORTED ERROR CODE 133.6090.0 (MAIN SPEAKER FAILURE) OCCURRED TWENTY-FIVE (25) TIMES FROM 08 MAY 2024 TO 07 AUGUST 2024. ¿ FURTHER REVIEW OF THE LOGS SHOWED, ON 08 MAY 2024 AT THE TIME OF POWER ON, THE PCU RECORDED BATTERY COMPLETELY DISCHARGED IN THE BATTERY LOG INDICATING THE BATTERY DEPLETED WHILE NOT IN USE. THERE WAS NO RECORD OF BATTERY CONDITIONING BEING PERFORMED. ¿ ON 27 JULY 2024 AT THE TIME OF POWER ON, THE PCU RECORDED BATTERY COMPLETELY DISCHARGED IN THE BATTERY LOG INDICATING THE BATTERY DEPLETED WHILE NOT IN USE. THERE WAS NO RECORD OF BATTERY CONDITIONING BEING PERFORMED ¿ LABORATORY TESTING FOUND THE PCU WAS OPERATING AS EXPECTED. ¿ THE SUSPECT PCU¿S BATTERY WAS OBSERVED TO BE ALMOST TWO (2) YEARS OLD IN AGE WITH A DATE CODE OF 2309 (27 FEBRUARY 2023 ¿ 07 MARCH 2023) ¿ SERVICE BULLETIN 529A STATED THAT FREQUENT USE OF BATTERY POWER AND INSUFFICIENT BATTERY CHARGING MAY DECREASE BATTERY LIFE. BD RECOMMENDS REPLACING THE BATTERY EVERY 2 YEARS AT MINIMUM, IF USED IN PROPER CONDITIONS. ¿ EXTERNAL AND INTERNAL INSPECTION FOUND INCIDENTAL FINDINGS ONLY WITH NO RELATION TO THE REPORTED COMPLAINT. ¿ THE BD ALARIS¿ PC UNIT (PCU) SOFTWARE RUNS SELF-CHECKING PROGRAMS PRIOR TO AND DURING OPERATION. A SYSTEM ERROR MESSAGE MEANS THAT THE BD ALARIS¿ SYSTEM HAS IDENTIFIED AN ERROR IN EITHER THE HARDWARE OR THE SOFTWARE OF THE PCU. ¿ OBTAIN A NEW PCU. DO NOT POWER DOWN UNTIL A NEW PCU IS AVAILABLE. TAG THE AFFECTED PCU, DESCRIBE THE ERROR AND RETURN IT TO YOUR FACILITY¿S CLINICAL ENGINEERING OR BIOMED DEPARTMENT. ¿ PER SERVICE BULLETIN 592A, THE PC UNIT IS SHIPPED WITH THE BATTERY IN A DISCHARGED CONDITION. BEFORE THE PC UNIT IS RELEASED FOR USE, IT SHOULD BE PLUGGED INTO A HOSPITAL GRADE AC OUTLET AND THE BATTERY CHARGED FOR AT LEAST 16 HOURS. THIS ENSURES PROPER BATTERY OPERATION WHEN THE ALARIS SYSTEM IS FIRST SET UP FOR PATIENT USE. ¿ LEAVE THE POWER CORD CONNECTED TO A HOSPITAL GRADE AC POWER SOURCE WHENEVER AVAILABLE. THE BATTERY IS INTENDED AS A BACKUP SYSTEM. ¿ THE BATTERY SHOULD BE FULLY CHARGED (16 HOURS) AT LEAST ONCE PER YEAR TO PREVENT LEAKAGE AND DETERIORATION IN PERFORMANCE DUE TO SELF-DISCHARGE. ¿ WHEN THE BATTERY HAS BEEN OUT OF USE FOR ONE OR MORE MONTHS, IT WILL NOT HAVE FULL CAPACITY. BATTERY CAPACITY MAY BE RESTORED BY PERFORMING THE BATTERY CONDITIONING TEST (FAST OR OPTIMAL CONDITIONING) IN MAINTENANCE MODE. ¿ THE BATTERY SHOULD BE REPLACED EVERY 2 YEARS BY QUALIFIED SERVICE PERSONNEL. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE TO REPAIR CENTER: DEVICE OPENED FOR INVESTIGATION. PLEASE RE-TORQUE ALL SCREWS. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT COVER THE COSTS ASSOCIATED WITH ANY INCIDENTAL FINDINGS OR PHYSICALLY ABUSED COMPONENTS. ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ERROR 133.6090.0 WAS NOT ABLE TO BE COMPLETELY IDENTIFIED DURING THE INVESTIGATION; HOWEVER, IT IS BEING ATTRIBUTED TO BE A BATTERY DETERIORATION ISSUE. THE SUSPECT PCU BATTERY IS APPROXIMATELY 2 YEARS IN AGE, AND LOG REVIEW SHOWED THE PCU ALARMING FOR VERY LOW BATTERY ALARM AND NO BATTERY CONDITIONING WAS NOTED IN THE BATTERY LOGS. NOTE THAT IMDRF ANNEX A040502, A09, C0201, C0601, D15, D02 AND G02035 CODES NOT ASSOCIATED WITH THE ROOT CAUSE 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

    ADDITIONAL INFORMATION: ANNEX A: A070504. ANNEX C: C02. 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: ALTHOUGH THE REPORT OF A SYSTEM ERROR CODE 133.6090 WAS CONFIRMED DURING LOG REVIEW, THE ERROR WAS NOT REPRODUCED DURING LABORATORY TESTING. REVIEW OF THE PCU ERROR LOG SHOWED, PRIOR TO THE ISSUE BEING REPORTED, THE REPORTED ERROR CODE 133.6090.0 (MAIN SPEAKER FAILURE) OCCURRED TWENTY-FIVE (25) TIMES FROM (B)(6) 2024 TO (B)(6) 2024. FURTHER REVIEW OF THE LOGS SHOWED, ON (B)(6) 2024 AT THE TIME OF POWER ON, THE PCU RECORDED BATTERY COMPLETELY DISCHARGED IN THE BATTERY LOG INDICATING THE BATTERY DEPLETED WHILE NOT IN USE. THERE WAS NO RECORD OF BATTERY CONDITIONING BEING PERFORMED. ON (B)(6) 2024 AT THE TIME OF POWER ON, THE PCU RECORDED BATTERY COMPLETELY DISCHARGED IN THE BATTERY LOG INDICATING THE BATTERY DEPLETED WHILE NOT IN USE. THERE WAS NO RECORD OF BATTERY CONDITIONING BEING PERFORMED LABORATORY TESTING FOUND THE PCU WAS OPERATING AS EXPECTED. THE SUSPECT PCU¿S BATTERY WAS OBSERVED TO BE ALMOST TWO (2) YEARS OLD IN AGE WITH A DATE CODE OF 2309 ((B)(6) 2023 ¿ (B)(6) 2023) EXTERNAL AND INTERNAL INSPECTION FOUND INCIDENTAL FINDINGS ONLY WITH NO RELATION TO THE REPORTED COMPLAINT. PER THE BD ALARIS¿ SYSTEM ERROR TIP SHEET, THE PC UNIT (PCU) SOFTWARE RUNS SELF-CHECKING PROGRAMS PRIOR TO AND DURING OPERATION. A SYSTEM ERROR MESSAGE MEANS THAT THE BD ALARIS¿ SYSTEM HAS IDENTIFIED AN ERROR IN EITHER THE HARDWARE OR THE SOFTWARE OF THE PCU. OBTAIN A NEW PCU. DO NOT POWER DOWN UNTIL A NEW PCU IS AVAILABLE. TAG THE AFFECTED PCU, DESCRIBE THE ERROR AND RETURN IT TO YOUR FACILITY¿S CLINICAL ENGINEERING OR BIOMED DEPARTMENT. THE BD ALARIS¿ USER MANUAL STATES THAT THE PCU IS SHIPPED WITH THE BATTERY IN A DISCHARGED CONDITION. BEFORE THE PCU IS RELEASED FOR USE, IT SHOULD BE PLUGGED INTO A HOSPITAL GRADE AC OUTLET AND THE BATTERY CHARGED FOR AT LEAST 16 HOURS. THIS ENSURES PROPER BATTERY OPERATION WHEN THE BD ALARIS¿ SYSTEM IS FIRST SET UP FOR PATIENT USE. THE BATTERY IS INTENDED AS A BACKUP SYSTEM. LEAVE THE POWER CORD CONNECTED TO AN EXTERNAL HOSPITAL GRADE AC POWER SOURCE WHENEVER AVAILABLE. WHEN THE BATTERY HAS BEEN OUT OF USE FOR ONE OR MORE MONTHS, IT WILL NOT HAVE FULL CAPACITY. BATTERY CAPACITY MAY BE RESTORED BY PERFORMING THE BATTERY CONDITIONING TEST (FAST OR OPTIMAL CONDITIONING) IN MAINTENANCE MODE. THE BATTERY SHOULD BE REPLACED EVERY 2 YEARS BY QUALIFIED SERVICE PERSONNEL. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED ERROR 133.6090.0 IS BEING ATTRIBUTED TO A DISCHARGED BATTERY AND IS TO A BATTERY DETERIORATION ISSUE. THE SUSPECT PCU BATTERY IS APPROXIMATELY 2 YEARS IN AGE, AND LOG REVIEW SHOWED THE PCU ALARMING FOR VERY LOW BATTERY ALARM. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A040502, G02035, C0601, D15, A09, C0201 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. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCU HAD THE ERROR CODE 133.6090. IT WAS ALSO NOTED THAT THERE WAS NOT AN INFUSION RUNNING AS THE ERROR OCCURRED DURING SET UP. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCU HAD THE ERROR CODE 133.6090. IT WAS ALSO NOTED THAT THERE WAS NOT AN INFUSION RUNNING AS THE ERROR OCCURRED DURING SET UP. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489756 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403516023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8100.