BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 14626003 · Received June 7, 2022

    Report

    Report Number
    3012307300-2022-11007
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Report Date
    March 17, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150292
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMERS REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF THE SERVICE AND REPAIR RECORDS. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION SHOWED TAMPER SEAL WAS MISSING. DURING FUNCTIONAL TESTING, THE REPORTED PROBLEM WAS NOT DUPLICATED. THE PUMP IS WITHIN THE SPECIFICATION OF PLUS OR MINUS 3 PERCENT. NO PROBLEM FOUND. NO REPAIRS NEEDED; PERFORMED PREVENTATIVE MAINTENANCE.

    Description of Event or Problem · 0

    ORACLE RO 1233200: IT WAS REPORTED THAT THE PUMP UNDER INFUSES. (RECENTLY REPAIRED ON RO (B)(4) FOR BUBBLED DSO SENSOR SEAL RETURNED 19-APR-2022). NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141533 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150292

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown