BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION

    MDR report key: 13417767 · Received February 1, 2022

    Report

    Report Number
    3012307300-2022-02307
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Report Date
    February 1, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A PUMP WITH A CADD CASSETTE RESERVOIR ATTACHED WAS INFUSING WITH THE CASSETTE AND TUBING OVER 24 HOURS AND REPORTED THE TUBING BECAME DISCONNECTED FROM THE CASSETTE AND THE LUER LOCK CONNECTION WAS SLIDING DOWN THE TUBING. IT WAS REPORTED THE LUER LOCK GROVES WERE NOT STRAIGHT AND THE THREADS DID NOT TIGHTEN CORRECTLY. PER REPORTER THE CARE GIVER DID NOT KNOW HOW THE TUBING BECAME DISCONNECTED AND THE END USER COMPLAINED THAT HIS STOMACH WAS HURTING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. MEDICATION: REMODULIN 1MG/ML, UNITED THERAPEUTICS DOSE: 111 NG/KG/MIN - INTRAVENOUS. FREQUENCY: CONTINUES, START DATE: (B)(6) 2018, LOT# 2101977, EXPIRATION DATE 03/31/2023, DIAGNOSIS: PULMONARY ARTERIAL HYPERTENSION (PAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486565 CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Male