BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 9205729 · Received October 17, 2019

    Report

    Report Number
    3012307300-2019-05593
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Report Date
    November 27, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126600
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO PATIENT INVOLVEMENT. EVALUATION RESULTS: ONE CADD SOLIS PUMP WAS RETURNED FOR INVESTIGATION IN GOOD CONDITION. A REVIEW OF THE EVENT HISTORY LOG EVIDENCED THE FOLLOWING: 9/19/2019 3:03:42 PM KEYPAD LOCKED, 9/19/2019 3:08:12 PM HIGH ALARM DISPLAYED: KEY STUCK, AND 9/19/2019 3:08:24 PM CASSETTE LATCH WAS OPENED. THE INVESTIGATOR EVALUATED THE DEVICE BY PERFORMING A KEYPAD FUNCTIONAL TEST AND POWER UP. THE INVESTIGATOR DETERMINED THAT ALL THE KEYPAD BUTTONS FUNCTIONED AS INTENDED. THE CUSTOMER REPORTED PRODUCT PROBLEM WAS NOT REPLICATED. THE KEYPAD WAS REPLACED AS A PREVENTATIVE MEASURE HOWEVER. A ROOT CAUSE WAS NOT ESTABLISHED AS THE PRODUCT PROBLEM WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD SOLIS VIP PUMP ALARMS KEY STOCKED. IT WAS NOT SPECIFIED WHETHER THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO REPORTED ADVERSE EFFECTS. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD SOLIS VIP PUMP ALARMS KEY STOCKED. IT WAS NOT SPECIFIED WHETHER THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999292 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability