BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 15255283 · Received August 18, 2022

    Report

    Report Number
    3012307300-2022-15641
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 30, 2022
    Report Date
    October 10, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. PROTOCOL #IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 25 AUGUST 2022 CLARIFIED THAT A PUMP, WITH A DIFFERENT SERIAL NUMBER THAN WAS ORIGINALLY REPORTED, WAS RECEIVED AND THE ORIGINALLY REPORTED SERIAL NUMBER WAS INCORRECT. H.6: EVENT PROBLEM AND EVALUATION CODE UPDATES WERE NOT REQUIRED. DEVICE EVALUATION 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., CORRECTED DATA: D4: CORRECTION: MODEL NUMBER. 2120. G5: CORRECTION: PREMARKET 510K NUMBER: K111275.

    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 SEALS. THE CUSTOMER STATED PROBLEM WAS NOT DUPLICATED. NO DEVICE PROBLEM WAS FOUND. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A DHR (DEVICE HISTORY 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 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

    IT WAS REPORTED THAT THE PUMP HAD A DELIVERY ACCURACY ISSUE AND FAILED THE VOLUME TEST. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817703 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown