BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY

    MDR report key: 13170396 · Received January 5, 2022

    Report

    Report Number
    3012307300-2022-00136
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Report Date
    June 7, 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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A1, H6, H10: INFORMATION WAS RECEIVED INDICATING THAT INDICATING THAT THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. NO PATIENT WAS INVOLVED.

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE WAS MISSING THE TAMPER SEAL. THE CUSTOMER STATED PROBLEM WAS NOT DUPLICATED. RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. NO DEVICE PROBLEM FOUND. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO MANUFACTURING RELATED CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING DHR REVIEW IS NEEDED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD-SOLIS VIP, MDL 2120, FAILED VOLUME ACCURACY TESTING, 18.832 AND 18.682.

    Description of Event or Problem · 0

    ORACLE RO 1200188: FAILED VOLUME ACCURACY TEST (18.832 AND 18.682) ADDITIONAL INFORMATION RECEIVED VIA EMAIL AND ATTACHED 10/JAN/2022: ERROR OCCURRED DURING TESTING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133272 CADD-SOLIS VIP AMBULATORY INFUSION PUMP FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown