BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 20085627 · Received August 28, 2024

    Report

    Report Number
    3012307300-2024-08234
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 28, 2024
    Manufacturer
    FRN
    Product Code
    FRN
    UDI-DI
    15019517126600
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: ONE DEVICE WAS RECEIVED FOR ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THAT THE DEVICE HAD NOT BEEN SERVICED IN THE PAST. VISUAL INSPECTION CONFIRMED THE REPORTED ISSUE. THE ROOT CAUSE OF THE PROBLEM WAS THE DOWNSTREAM OCCLUSION (DSO) SEAL. THE DSO SEAL WAS REPLACED TO CORRECT THE PROBLEM. THE DEVICE THEN PASSED ALL FUNCTIONAL TESTS AFTER THE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DOWNSTREAM OCCLUSION SEAL (DSO) DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479183 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN FRN 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown