BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS HPCA PUMP

    MDR report key: 20510414 · Received October 22, 2024

    Report

    Report Number
    3012307300-2024-11767
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 22, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    MEA
    UDI-DI
    10610586038778
    PMA / PMN Number
    K130394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: ADDRESS LINE 2 "PHILIPS NORTH AMERICA, (B)(6). H3: ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS WORN. SERVICE HISTORY IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING DUPLICATED THE CUSTOMER REPORTED ISSUE IF THE CORRODED BATTERY COMPARTMENT. THE DSO SEAL WAS REPLACED, ALONG WITH THE BATTERY COMPARTMENT.

    Description of Event or Problem · 0

    ONE DEVICE WAS RETURNED AND ANALYSIS FOUND THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS WORN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33293 CADD-SOLIS HPCA PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC 2110 10610586038778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown