BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 8126427 · Received December 3, 2018

    Report

    Report Number
    3012307300-2018-08668
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Report Date
    October 28, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRZ
    PMA / PMN Number
    K000842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE DEVICE RECEIVED IN GOOD PHYSICAL CONDITION. ABLE TO DUPLICATE THE REPORTED PROBLEM DURING FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD (DHR) REVIEW IS NOT APPLICABLE OR RELEVANT BECAUSE THIS DEVICE IS NOT AN OUT OF BOX FAILURE AND/OR THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OR REPAIR OF THE DEVICE. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN. BASED ON THESE INVESTIGATION RESULTS, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. SMITHS MEDICAL REGULARLY ANALYZES PRODUCT COMPLAINT DATA AND TRENDS, AND WILL TAKE FURTHER ACTIONS ACCORDINGLY. D4: UDI INFORMATION IS UNKNOWN. G5: PREMARKET (510K) NUMBER IS UNKNOWN.

    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 OVER INFUSED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963212 CADD PUMP, INFUSION FRZ ST PAUL 6101
    963231 CADD PUMP, INFUSION FRZ ST PAUL 6101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown