BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 14063640 · Received April 8, 2022

    Report

    Report Number
    3012307300-2022-06091
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Report Date
    June 10, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 12-MAY-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: NO PATIENT INVOLVEMENT. THE ISSUE OCCURRED DURING TESTING. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE WAS MISSING THE TAMPER SEAL. THE CUSTOMER STATED PROBLEM WAS DUPLICATED. REPLACED FAULTY DOWNSTREAM OCCLUSION SENSOR. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A REVIEW OF THE MANUFACTURING FLOW I DHR (21-2120-0105-01 JOB 4082657 AND 67-2486 JOB 4062297) FOR THIS DEVICE FOUND NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER REPORTED FAILURE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CADD-SOLIS VIP AMBULATORY INFUSION PUMP OUT OF BOX FAILURE READS CASSETTE NOT ATTACHED PROPERLY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161161 CADD SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 21-2120-0105-01 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown