BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 15341704 · Received September 1, 2022

    Report

    Report Number
    3012307300-2022-17376
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Report Date
    November 10, 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

    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

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION OF THE DEVICE FOUND THE TAMPER SEALS INTACT. FIRST TIME IN FOR SERVICE. THERE WAS NO EVIDENCE OF THE ERROR IN THE EVENT HISTORY LOG. THE CUSTOMER REPORTED PROBLEM WAS VERIFIED. THE INVESTIGATION FOUND THAT THE DOWNSTREAM OCCLUSION SENSOR WAS INOPERABLE (STUCK), BUT WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. FOR CORRECTIVE ACTION, THE DOWNSTREAM OCCLUSION SENSOR WAS REPLACED. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. REVIEWED THE DEVICE HISTORY RECORD FOR JOB 4191087. THERE WAS NO EVIDENCE OF ISSUES DURING THE 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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831511 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown