BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD PRIZM VIP PUMP

    MDR report key: 8180886 · Received December 19, 2018

    Report

    Report Number
    3012307300-2018-08843
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Report Date
    February 4, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K000842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD PRIZM VIP PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP FOUND THE PUMP IN GOOD PHYSICAL CONDITION. THE REPORTED EVENT WAS FOUND IN DEVICE EVENT LOG. 083> ERROR DETECTED 10040 13:03 10/08/18 FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP WAS POWERED UP AND NO ERROR CODE WAS OBSERVED. THE CUSTOMER REPORTED EVENT COULD NOT BE DUPLICATED. BASED ON THE EVIDENCE, THE COMPLIANT WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD PRIZM VIP PUMP DISPLAYED ERROR CODE 10040. 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
    1020449 CADD PRIZM VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6101

    Patients

    Seq Age Sex Outcome Treatment
    1