BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 14626108 · Received June 7, 2022

    Report

    Report Number
    3012307300-2022-11011
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Report Date
    August 8, 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
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON (B)(6)-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: ALL ISSUES WITH THESE PUMPS WERE FOUND DURING TESTING AND REPAIR AT OUR FACILITY. NO PATIENT INVOLVEMENT WAS INDICATED TO ME, OR OUR TECHNICIAN, AT THE TIME WE RECEIVED THE PUMP FOR SERVICE AT OUR FACILITY. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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. ERROR WAS FOUND IN THE DEVICE EHL (EVENT HISTORY LOG). THE CUSTOMER STATED PROBLEM WAS DUPLICATED. DURING INVESTIGATION, FOUND LATCH/LOCK OPTIC FLEX CIRCUIT NON-FUNCTIONING. REPLACE DEFECTIVE LATCHED OPTIC FLEX SENSOR AND MISSING BATTERY DOOR. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OR LAST REPAIR OF THE DEVICE. NO MANUFACTURING OR SERVICE ISSUES WERE IDENTIFIED AS CAUSES OF THE CUSTOMER'S REPORTED PROBLEM DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING OR SERVICE RECORDS REVIEW IS NEEDED.

    Description of Event or Problem · 0

    ORACLE RO 1233078: REASON FOR RETURN: IT WAS REPORTED THAT THE LATCH/LOCK SENSOR WAS BAD. PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602055 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown