BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11659201 · Received April 13, 2021

    Report

    Report Number
    3012307300-2021-03088
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 9, 2021
    Report Date
    August 11, 2021
    Product Code
    FPA
    UDI-DI
    15019517161953
    PMA / PMN Number
    K031361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H3: ONE CADD ADMINISTRATION SET FROM PART NUMBER: 21-7346-24 AND LOT NUMBER: 3984202 WAS RECEIVED IN DECONTAMINATED CONDITION AND INSIDE APLASTIC BAG WITHOUT THE ORIGINAL PACKAGE. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION; NO VISUAL DISCREPANCIES WERE DETECTED. THE SAMPLE WAS SET FOR ACCURACY TESTING USING A CADD LEGACY PUMP AND A BALANCE METTLER TOLEDO TO LOOK FOR UNUSUAL FUNCTION. THE SAMPLE PASSED THE TEST AND THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THERE WAS NO FAULT FOUND WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT THE PUMP ADMINISTERED THE MEDICATION CORRECTLY AS PROGRAMMED, YET THE VOLUME IN THE MEDICATION BAG DID NOT MATCH THE VOLUME IN THE PUMP AFTER ALL THE DOSES WERE INFUSED. THE PUMP STATED THAT 22.3ML MEDICATION WAS LEFT IN THE BAG, BUT THE BAG SHOWED APPROXIMATELY 1OO ML LEFT. THE PUMP WAS CHANGED TO ENSURE THE IT WAS WORKING PROPERLY, BUT THE SAME RESULTS OCCURRED. THE TUBING WAS CHANGED, AND THE ISSUE RESOLVED; ALL MEDICATION INFUSED PROPERLY. THE DEFECTIVE TUBING REPORTEDLY HAD NO VISIBLE DEFECTS. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553473 CADD INTRAVASCULAR ADMINISTRATION SET FPA 21-7346-24 3984202 15019517161953

    Patients

    Seq Age Sex Outcome Treatment
    1