BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 15402101 · Received September 12, 2022

    Report

    Report Number
    3012307300-2022-18688
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Report Date
    September 12, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126600
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED DEVICE DID NOT DUPLICATE THE REPORTED PROBLEM. WHEN TESTED IN USER MODE THE PUMP RAN NORMALLY. THE AIR IN LINE SENSOR REPORTED PASS IN THE STATUS MENU. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. OPERATOR OF DEVICE IS UNKNOWN. INITIAL REPORTER ALSO SENT REPORT TO FDA IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS PRESENTING WITH AIR IN LINE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140267 CADD SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown