BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP KIT

    MDR report key: 14566900 · Received June 1, 2022

    Report

    Report Number
    3012307300-2022-10328
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Report Date
    August 11, 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 HAS BEEN RECEIVED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. OPERATOR OF DEVICE AND INITIAL REPORTER ALSO SENT REPORT TO FDA?- ARE UNKNOWN.

    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. NO PATIENT INVOLVEMENT WAS INDICATED TO ME, OR OUR TECHNICIAN, AT THE TIME THE PUMP WAS RECEIVED FOR REPAIR IN OUR FACILITY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL. THE REPORTED PROBLEM WAS DUPLICATED. THE PUMP WAS FOUND TO BE DISPLAYING A "CASSETTE NOT ATTACHED PROPERLY" ALARM MESSAGE, DURING THE INVESTIGATION. A FAULTY DOWNSTREAM OCCLUSION SENSOR WILL BE REPLACED. NCR-000979 WAS OPENED TO INVESTIGATE THE RISE IN INCORRECT/NO CASSETTE/DISPOSABLE DETECTED ISSUES. (UPDATED H3 AND H6). 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., CORRECTED DATA: THE MODEL NUMBER WAS INCORRECTLY DOCUMENTED, IN THE INITIAL REPORT. (UPDATED D4A).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FAILED CALIBRATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600821 CADD-SOLIS VIP AMBULATORY INFUSION PUMP KIT PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown