BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS AMBULATORY INFUSION PUMP, FRENCH

    MDR report key: 20076624 · Received August 27, 2024

    Report

    Report Number
    3012307300-2024-08159
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    UDI-DI
    15019517135350
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE EVENT HISTORY LOG WAS DOWNLOADED. VISUAL, FUNCTIONAL, OCCLUSION AND ACCURACY TESTS WERE PERFORMED. IT WAS FOUND THAT THE DEVICE DOESN'T HOLD PATIENT DATA AND THERE WAS A DAMAGED DOWNSTREAM OCCLUSION (DSO) SEAL. A DEFECTIVE PRINTED WIRE ASSEMBLY (PWA) WAS ALSO FOUND. THE PRIMARY PROBLEM WAS THE PWA. THE DSO SEAL AND THE PWA WERE REPLACED TO FIX THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE IS FOR REPAIR. THE INVESTIGATION FOUND A DAMAGED DOWNSTREAM OCCLUSION (DSO) SEAL AND A DEFECTIVE PRINTED WIRE ASSEMBLY (PWA). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26108 CADD-SOLIS AMBULATORY INFUSION PUMP, FRENCH PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110 15019517135350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown