BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 14630933 · Received June 8, 2022

    Report

    Report Number
    3012307300-2022-11055
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Report Date
    December 15, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126600
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE CUSTOMERS REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE TAMPER SEAL MISSING. THERE WAS NO EVIDENCE OF THE ERROR RECORDED IN EVENT HISTORY LOG. THE REPORTED PROBLEM WAS DUPLICATED. WHEN POWERING UP THE DEVICE, DISPLAYED CONSTANT ALARM ERROR CODE 45985. THE DEFECTIVE MICROPROCESSOR UNIT BOARD WAS REPLACED AS CORRECTIVE ACTION AS THIS WAS THE CAUSE OF THE REPORTED PROBLEM. THE ROOT CAUSE OF REPORTED WAS UNKNOWN. PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY., CORRECTED DATA: CORRECTION: D4: CATALOG NUMBER: 21-2127-0104-01. CORRECTION: D4: MODEL NUMBER: 2120.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP EXHIBITED AN ERROR WITH A RED SCREEN WHEN POWERED ON. THE PUMP WAS NON-RESPONSIVE 45985 1864003. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23803 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown