BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11667971 · Received April 14, 2021

    Report

    Report Number
    3012307300-2021-03138
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Report Date
    August 11, 2021
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H3: FIVE PICTURES OF A CADD CASSETTE RESERVOIR WERE RECEIVED FOR EVALUATION. NO ANOMALIES WERE OBSERVED IN THE PICTURES THAT MAY AFFECT THE FUNCTIONALITY OF THE PRODUCT. TWENTY FOUR CADD CASSETTE RESERVOIRS WITH PART NUMBER: 21-7302-24, LOT NUMBER: 4092490 WERE RECEIVED IN NEW CONDITION IN THEIR ORIGINAL CLOSED PACKAGE. THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT SAMPLES CONDITIONS THAT COULD CAUSE FUNCTIONAL ISSUES. THE SAMPLES DIDN?T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. THE SAMPLES WERE FILLED WITH WATER AND CONNECTED TO A CADD LEGACY PLUS PUMP TO LOOK FOR UNUSUAL FUNCTION. THE SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTY, THE PUMP WERE SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE REPORTED ISSUE WAS NOT CONFIRMED. THERE WAS NO FAULT FOUND WITH THE RETURNED CASSETTES.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD CASSETTE RESERVOIR. IT WAS REPORTED THAT PATIENT INVOLVED RECEIVED AN ERROR MESSAGE STATING, "NO DISPOSABLE PUMP- WON'T RUN." THE MESSAGE WAS RECEIVED ANYWHERE FROM 2 HOURS AFTER INFUSION BEGAN TO 12 HOURS AFTER. THE PUMP WAS USED THE DAY BEFORE WITH NO ERROR MESSAGES. AFTER TROUBLESHOOTING, THE PUMP INFUSED SUCCESSFULLY FOR 10 MINUTES WITH A DIFFERENT CASSETTE FROM A DIFFERENT LOT. THERE WERE THREE PATIENTS INVOLVED IN THIS INCIDENT. AS A RESULT, SOME PATIENTS WERE UNABLE TO GET CHEMO THERAPY FOR SEVERAL HOURS. THEY HAD TO GO TO THE EMERGENCY ROOM. NO INJURIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561912 CADD INTRAVASCULAR ADMINISTRATION SET FPA 21-7302-24 4092490 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1