BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD®-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 8030310 · Received November 1, 2018

    Report

    Report Number
    3012307300-2018-08078
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Report Date
    December 6, 2018
    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

    ONE CADD SOLIS VIP 2120 PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP SHOWED THAT PUMP WAS IN GOOD PHYSICAL CONDITION. THE REVIEW OF EVENT HISTORY LOG IDENTIFIED FOLLOWING EVENTS IN HISTORY: "ON (B)(6) 2005 12:00:02 AM STANDARD BATTERY AT 50%. ON (B)(6) 2005 12:00:09 AM MEDIUM ALARM DISPLAYED: PUMP SETTINGS AND PATIENT DATA LOST. ON (B)(6) 2005 12:00:11 AM MEDIUM ALARM ACKNOWLEDGED: PUMP SETTINGS AND PATIENT DATA LOST. ON (B)(6) 2005 12:00:14 AM POWER UP COMPLETE. FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP WAS POWERED ON AND IT IMMEDIATELY GAVE "PUMP SETTINGS AND PATIENT DATA LOST" ALARM. BASED ON THE EVIDENCE THE COMPLAINT WAS CONFIRMED. ROOT CAUSE WAS ATTRIBUTED TO FAULTY MICROPROCESSOR BOARD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS AMBULATORY INFUSION PUMP WOULD NOT RETAIN THE SET DATE AND TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869552 CADD® CADD®-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention