BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD

    MDR report key: 15254972 · Received August 18, 2022

    Report

    Report Number
    3012307300-2022-15634
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Report Date
    November 9, 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
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 IF ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. OPERATOR OF DEVICE IS UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 06-SEP-2022 VIA EMAIL AND ATTACHED IN COMPLAINT OBJECT: THERE WAS NO PATIENT OR TECHNICIAN INVOLVEMENT WAS INDICATED AT THE TIME THE PUMP WAS RECEIVED AT OUR FACILITY FOR REPAIR. ALL ISSUES FOUND WITH THIS DEVICE WERE FOUND DURING TESTING AT OUR FACILITY. 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., CORRECTED DATA: D4: CORRECTION: MODEL NUMBER: 2120.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER: UPDATED. 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 TAMPER SEAL WAS MISSING UPON RECEIPT. ERROR CODES WERE NOT FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED ISSUE WAS NOT DUPLICATED DURING THE INVESTIGATION AS THE DEVICE WAS READING THE CASSETTES USED DURING THE FUNCTIONAL TESTS AND THE DEVICE PASSED ALL TESTS. ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN AS NO FAULT WAS FOUND. NO REPAIRS WERE MADE, ONLY PREVENTIVE MAINTENANCE WAS PERFORMED. A NONCONFORMANCE REPORT (NCR) WAS CREATED TO INVESTIGATE THE INCORRECT/NO CASSETTE, NO DISPOSABLE DETECTED ISSUE, WHICH IS ONGOING. REVIEWED THE DEVICE HISTORY RECORD DHR FOR JOB 4233209 WHICH INCLUDED THE REPORTED SERIAL NUMBER. THERE WAS NO INDICATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CASSETTE ISSUE ERROR OCCURRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847661 CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown