BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 15189102 · Received August 8, 2022

    Report

    Report Number
    3012307300-2022-15007
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Report Date
    October 24, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. OPERATOR OF DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION WAS RECEIVED ON 29-AUG-2022 AND ATTACHED IN THE COMPLAINT OBJECT. ALL ISSUES WITH THIS DEVICE WERE FOUND DURING TESTING AT OUR FACILITY. NO PATIENT INVOLVEMENT WAS INDICATED TO ME, OR OUR TECHNICIAN, AT THE TIME THE PUMP WAS RECEIVED AT OUR FACILITY FOR REPAIR AND RECERTIFICATION.H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED., CORRECTED DATA: D4: CORRECTION: CATALOG NUMBER: 01-2120-0104-01, D4: CORRECTION: MODEL NUMBER: 2120

    Additional Manufacturer Narrative · 0

    H6: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE DEVICE WAS MISSING THE TAMPER SEAL AND BATTERY DOOR. THE EVENT LOG SHOWED NO EVIDENCE OF THE REPORTED PROBLEM. UPON FUNCTION TESTING, THE REPORTED PROBLEM WAS DUPLICATED. THE AIR DETECTOR WAS FOUND TO BE INOPERABLE. THE ROOT CAUSE OF THE REPORTED PROBLEM IS UNKNOWN. THE SENSOR WAS REPLACED TO RESOLVE THE ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP EXHIBITED AN AIR IN LINE ERROR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988029 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown