BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 20086915 · Received August 28, 2024

    Report

    Report Number
    3012307300-2024-08145
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 25, 2024
    Report Date
    September 25, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). NEITHER SAMPLES OR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 4060908 WAS REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. COMPLAINT FOR THE FAILURE MODE "A0095 - CAUSES PUMP TO ALARM" COULD NOT BE CONFIRMED BY INVESTIGATION AS NO SAMPLES NOR PICTURES WAS PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE USED SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF THE FILE, IT WAS DISCOVERED THAT THE FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. THERE WAS NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. 3012307300-2024-08145 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE HOSE GIVES AN OVERPRESSURE ALARM WHEN CONNECTED CORRECTLY. THEY HAVE NOT NOTICED ANY PROBLEMS WITH THE PUMP, ONLY WITH THE ACCESSORIES, THE REPLACEMENT PUMP REPORTS THE SAME ALARM. THE INCIDENT OCCURRED WHILE CHANGING CASSETTES AND EXTENSION SETS. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520836 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4060908 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown