BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS HPCA PUMP

    MDR report key: 21802212 · Received April 8, 2025

    Report

    Report Number
    3012307300-2025-03982
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    June 5, 2024
    Report Date
    April 8, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO CONFIRM COMPLAINT DUE TO THE DEVICE NOT BEING RETURNED. BASED ON THE REVIEW OF THE SERVICE HISTORY AND INFORMATION PROVIDED FROM THE CUSTOMER WE ARE UNABLE TO DETERMINE A PROBABLE CAUSE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. CUSTOMER'S REPORTED PROBLEM OF 16 DEVICE HAD A WIRELESS COMMUNICATION LOSS ERROR THAT STOPPED THE PUMP FROM WORKING COULD NOT BE DUPLICATED. THE REPORTED CADD SOLIS PUMP PART# 21-211-0402-51 /SN# (B)(6) WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, TWENTY (20) COMM MODULES PART# 21-2131-01 WERE RETURNED AND EVALUATED WITHOUT THE PUMP. EVALUATION FINDING WAS AS FOLLOW: 3 OF 20 COMM MODULES FAILED TO OPERATE, 5 OF 20 INTERNAL COMM MODULES BATTERIES NOT CONNECTED BY THE USER PER INSTRUCTIONS IN MODULE IFU. 12 OF 20 COMM MODULES OPERATED AS INTENDED. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 17 DEVICES HAD A WIRELESS COMMUNICATION LOSS ERROR THAT STOPPED THE PUMP FROM WORKING. THERE WAS NO PATIENT INVOLVEMENT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441310 CADD SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown