BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 9215598 · Received October 21, 2019

    Report

    Report Number
    3012307300-2019-05594
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    February 19, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. DURING THE EVALUATION OF THE DEVICE THEY WERE UNABLE TO CONFIRM THE CUSTOMER'S STATED PROBLEM. THE AIR DETECTOR OF THE DEVICE WORKS WITHOUT ISSUES. THE PUMP PASSED ALL TESTS. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD SOLIS VIP PUMP HAD AN AIR BUBBLE IDENTIFIED AFTER 4 TO 6 HOURS OF THE PARENTERAL TREATMENT. THE PUMP HAD RETURNED FROM MAINTENANCE WHEN THE ISSUE OCCURRED. THE ISSUE OCCURRED ON SEVERAL OCCASIONS WITH 4 PATIENTS. THE CADD SOLIS VIP PUMP WAS USED WITH CADD ADMINISTRATION SETS, BUT THE CUSTOMER WAS UNSURE OF THE LOT NUMBERS. LOT NUMBERS 378 0549, 381 5230, 382 3337 WERE PROVIDED FOR THE ADMINISTRATION SETS. THERE WERE NO REPORTED ADVERSE EVENTS FOR ANY OF THE 4 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008916 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 CADD ADMINISTRATION SET