BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP

    MDR report key: 9683502 · Received February 7, 2020

    Report

    Report Number
    3012307300-2020-01092
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Report Date
    February 7, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ONE CADD SOLIS VIP WAS RETURNED FOR INVESTIGATION IN USED CONDITION. THEM TAMPER SEAL WAS MISSING AND THE LENS WAS DAMAGED. A REVIEW OF THE EVENT HISTORY LOG EVIDENCED THE FOLLOWING: "ON (B)(6) 2018 11:36:37 AM MEDIUM ALARM DISPLAYED: CANNOT START PUMP. ON (B)(6) 2018 11:36:42 AM MEDIUM ALARM ACKNOWLEDGED: CANNOT START PUMP. ON (B)(6) 2018 11:36:45 AM MEDIUM ALARM DISPLAYED: CANNOT START PUMP. ON (B)(6) 2018 11:36:46 AM MEDIUM ALARM SILENCED: CANNOT START PUMP." THE CUSTOMER REPORTED PRODUCT PROBLEM WAS REPLICATED. THE FAULTY MAIN PCB WAS REPLACED AS A RESULT. THE PROBLEM SOURCE OF THE REPORTED PRODUCT PROBLEM WAS UNKNOWN. A ROOT CAUSE WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP "FAILED AIL TEST". THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146365 CADD SOLIS VIP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1