BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 15341767 · Received September 1, 2022

    Report

    Report Number
    3012307300-2022-17377
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Report Date
    November 11, 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

    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 CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE DEVICE MISSING A STICKER SEAL. THERE WAS NO EVIDENCE OF THE ERROR IN THE EVENT HISTORY LOG. THE REPORTED PROBLEM WAS DUPLICATED. THE DEVICE WAS FOUND TO BE DISPLAYING CASSETTE NOT ATTACHED PROPERLY AND AIR IN LINE ALARM MESSAGES DURING THE INVESTIGATION. THE INVESTIGATION FOUND THAT A DEFECTIVE OCCLUSION SENSOR AND AIR DETECTOR WERE THE CAUSE OF THE REPORTED PROBLEM. FOR CORRECTIVE ACTION THE DOWNSTREAM OCCLUSION SENSOR AND AIR DETECTOR WERE REPLACED. THE ROOT CAUSE OF REPORTED PROBLEM WAS UNKNOWN. REQUESTED THE DEVICE HISTORY RECORD FOR JOB 4191087. THERE IS NO EVIDENCE OF ANY ISSUE 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.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED ON 19-SEP-2022 VIA EMAIL ATTACHED IN COMPLAINT OBJECT: ALL ISSUES FOUND WITH THESE DEVICES WERE FOUND DURING TESTING AT OUR FACILITY. NO PATIENT OR TECHNICIAN INVOLVEMENT WAS INDICATED AT THE TIME THE PUMP WAS RECEIVED AT THE FACILITY FOR REPAIR AND RECERTIFICATION. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. D10: DEVICE AVAILABLE FOR EVALUATION: UPDATED. H10: 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.

    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
    1808362 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown