BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 11841665 · Received May 18, 2021

    Report

    Report Number
    3012307300-2021-04514
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 19, 2021
    Report Date
    December 20, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. THREE SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE RECEIVED NEW CONDITION WITH ORIGINAL PACKAGING CLOSED. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OBSERVED THE SAMPLES DIDN'T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. DURING FUNCTIONAL TESTING, THE SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTLY, THE PUMP WAS SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE COMPLAINT WAS NOT CONFIRMED AND NO ACTIONS WERE TAKEN. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THIS ISSUE WILL BE MONITORED FOR ANY INCREASE IN OCCURRENCE. IF THE OCCURRENCE OF THIS ISSUE INCREASES SIGNIFICANTLY, ADDITIONAL INVESTIGATIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS INVOLVED ARE 4092492, 4092493, 4060911, 4076292. ADDITIONAL CONTACT: (B)(4). PRODUCT COMPLAINT ANALYST.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD CASSETTE RESERVOIR CAUSED "NO DISPOSABLE" ALARMS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741427 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown