BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 8787105 · Received July 12, 2019

    Report

    Report Number
    3012307300-2019-03065
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Report Date
    March 11, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10. ONE CADD SOLIS VIP PUMPS - 2120 WAS RETURNED FOR ANALYSIS WITH THE TAMPER SEAL MISSING AND A DAMAGED LENS. THE DEVICE WAS ASSESSED USING THE POWER UP PROCESS, VISUAL AND FUNCTIONAL TESTING. THE REPORTED ISSUE OF A RED SCREEN WITH AN ALARM WAS NOT ABLE TO BE DUPLICATED. ERROR CODE 46515 REFERS TO IRQ NESTING. IT'S RECOMMENDED THAT THE BOARD BE REPLACED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS CADD SOLIS VIP AMBULATORY INFUSION PUMP ALARMED WITH A RED SCREEN DURING A MORPHINE ADMINISTRATION. THE ALARM WAS NOT ABLE TO BE RESOLVED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578901 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120

    Patients

    Seq Age Sex Outcome Treatment
    1