BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 21893132 · Received April 23, 2025

    Report

    Report Number
    3012307300-2025-04706
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 23, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586020315
    PMA / PMN Number
    K942046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE LOT NUMBERS PROVIDED: 6026890, 6061879, 6061870. H3: THE DEVICE HISTORY RECORD OF REPORTED POSSIBLE LOTS 6026890, 6061879, 6061870 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 COULD NOT BE CONFIRMED BY INVESTIGATION AS NO SAMPLES NOR PICTURES WAS PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP HAD ALARMED DOWNSTREAM OCCLUSION IN THE TUBING. PER REPORTER, IT WAS DIFFICULT TO DETERMINE WHETHER THERE WAS AN OCCLUSION IN THE TUBING, AS IT HAD APPEARED RELATIVELY CLEAR WITH MINIMAL TO NO BUBBLES. REPORTER STATED THE ALARM REMAINED UNRESOLVED AFTER THE INSPECTION OF THE TUBING. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257387 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. NI 10610586020315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown