BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS HPCA PUMPS

    MDR report key: 22778899 · Received August 11, 2025

    Report

    Report Number
    3012307300-2025-09525
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    MEA
    UDI-DI
    15019517154856
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. A REMOTE REVIEW OF THE DEVICE EVENT LOG WAS CONDUCTED, AND CONFIRMED THAT AN ALARM HAD BEEN PREVIOUSLY ACTIVATED, BUT THERE WAS NO ROOT CAUSE ESTABLISHED FOR THIS ALARM. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D4 - PRIMARY UDI NUMBER: CORRECTION. H6. CODES: UPDATED. DEVICE EVALUATION: NO PRODUCT WAS RETURNED FOR EVALUATION. THIS SUMMARY ANALYZES THE EVENT LOGS FROM THE REPORTED DEVICE COVERING THE PERIOD FROM JULY 28, 2025, TO JULY 29, 2025. FINDINGS: THE PUMP OPERATED WITHIN CONFIGURED PARAMETERS, WITH NO CONTINUOUS FLOW OR MVO (MANUAL VOLUME OVERRIDE) RECORDED. THE OCCLUSION ALARMS OCCURRED DURING INFUSION, SUGGESTING A POTENTIAL ISSUE WITH THE ADMINISTRATION SET OR UPSTREAM SENSOR, THOUGH NO SPECIFIC ERROR CODES BEYOND THE ALARM WERE LOGGED. THE PURGE AND BOLUS ADJUSTMENTS INDICATE USER INTERVENTION, BUT THE PERSISTENT ALARMS DESPITE THESE ACTIONS POINT TO AN UNRESOLVED MECHANICAL OR SETUP ISSUE. CONCLUSION: THE EVENT LOGS CONFIRM MULTIPLE UPSTREAM OCCLUSION ALARMS ON (B)(6) 2025, BETWEEN 01:01:12 AND 01:02:02, DURING A PROGRAMMED INTERMITTENT EPIDURAL BOLUS (PIEB) PROTOCOL INFUSION. THE LACK OF DEVICE RETURN FOR PHYSICAL EVALUATION LIMITS CONFIRMATION OF THE ROOT CAUSE, BUT THE LOGS SUGGEST A POSSIBLE ADMINISTRATION SET MALFUNCTION OR SENSOR SENSITIVITY ISSUE. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DESPITE HAVING REMOVED THE ADMINISTRATION SET AND PUT IT BACK IN, THE DEVICE STILL DISPLAYS AN OCCLUSION ALARM UPSTREAM. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171587 CADD SOLIS HPCA PUMPS PUMP, INFUSION, PCA MEA ICU MEDICAL, INC. 2110 15019517154856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown