BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 20021777 · Received August 21, 2024

    Report

    Report Number
    3012307300-2024-07903
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    December 15, 2023
    Report Date
    August 20, 2024
    Manufacturer
    6000 NATHAN LN N
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2024-00047. THE DATE OF THAT SUBMISSION WAS 15 JAN 2024. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DID NOT GET THE FULL DOSE. PER REPORTER THE DEVICE EXHIBITED BEEPING. CONTINUOUS INFUSION RATE: 2.2 ML/HR. RESERVOIR VOLUME: ORIGINAL 100 ML. GIVEN: 58.7 ML. REMAINING: 41.3 ML. DRUG: FLUOROURACIL. LENGTH OF INFUSION: 46 HOURS. LOCK LEVEL: LOCKED. THERE WAS A CSTD USED TO FILL CASSETTE. THE PUMP WAS USED TO PRIME THE EXTENSION TUBING. EVENT OCCURRED WHILE IN USE WITH PATIENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. 21-7047-24 4381330 TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272283 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA 6000 NATHAN LN N 4396119 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CSTD| EXTENSION SET| FLUOROURACIL