BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SETS

    MDR report key: 14246185 · Received April 28, 2022

    Report

    Report Number
    3012307300-2022-07125
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Report Date
    May 5, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    15019517161953
    PMA / PMN Number
    K031361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED, OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW.

    Description of Event or Problem · 0

    (4/5, REFERENCE (B)(4) FOR RELATED COMPLAINTS) IT WAS REPORTED THAT UNDER- INFUSIONS OCCURRED WITH CADD PUMPS FOR (AMPICILLIN, CLOXICILLIN, PENICILLIN G). AT ITS BEST, IT WOULD UNDER-INFUSE BY AT LEAST 10% OF TOTAL MEDICATION VOLUME. AT THE HIGHEST, IT HAS UNDER-INFUSED BY NEARLY 50% OF TOTAL VOLUME. THIS HAS BEEN THE CASE FOR 5 DIFFERENT CLIENTS OF OURS. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 09 MAY 2022: NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110122 CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7346-24 4235006 15019517161953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown