BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 14734898 · Received June 17, 2022

    Report

    Report Number
    3012307300-2022-12103
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Report Date
    November 8, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150292
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: A SAMPLE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE LABELS ARE UNDAMAGED, BUT THE TAMPER SEAL WAS MISSING UPON RECEIPT. ERROR CODES WERE NOT FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED ISSUE WAS CONFIRMED DURING THE INVESTIGATION AS THE DOWNSTREAM OCCLUSION SENSOR SEAL EXHIBITED A BUBBLE. ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN, BUT THE DOWNSTREAM OCCLUSION SEAL HAS A BUBBLE AND SHOWED SIGNS OF DEGRADATION. THE DOWNSTREAM OCCLUSION SENSOR SEAL WILL BE REPLACED. A CAPA HAS BEEN CREATED FOR DOWNSTREAM OCCLUSION SEAL REPLACEMENT INCREASE WHICH IS ONGOING. REVIEWED THE DEVICE HISTORY RECORD DHR FOR JOB 4174234 WHICH INCLUDES SERIAL NUMBER REPORTED. THERE WAS NO INDICATION OF ANY ISSUES DURING MANUFACTURE OF THIS DEVICE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY., CORRECTED DATA: D4: CORRECTION: MODEL NUMBER: 2120.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SERIAL NUMBER CORRECTION: 1240627. CORRECTION: DEVICE MANUFACTURING DATE: 24-AUG-2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OCCLUSION SENSOR SEAL WAS BUILDING UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224268 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150292

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown