BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXT SET

    MDR report key: 13282102 · Received January 14, 2022

    Report

    Report Number
    MW5106684
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Report Date
    November 29, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS CALL: PATIENT REPORTED "HIGH PRESSURE" ALARM ON ONE OF THE PUMPS AS SHE WAS SWITCHING TO NEW CASSETTE. PATIENT TRIED THE CASSETTE ON PREVIOUS PUMP AND IT WAS WORKING FINE SO IT WASN'T A FAULTY CASSETTE. PATIENT DIDN'T HAVE ANY VISIBLE BLOCKAGE ON THE DRUG PATHWAY. THE TUBING WAS PLACED CORRECTLY AS WELL. PATIENT CHANGED TUBING TO NEW ONE AND THE "HIGH PRESSURE" ALARM WENT AWAY. THE LOT NUMBER IS 4163597. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IS THE PRODUCT AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES. DID WE REPLACE THE DEVICE? PT ALREADY HAD NEW TUBING ON HAND. IS THE INFUSION LIFE SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. HAS THIS INCIDENT HAPPENED WITHIN THE PAST 6 MONTHS? NO. NO OTHER INFORMATION PROVIDED AT THIS TIME. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216170 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4163597

    Patients

    Seq Age Sex Outcome Treatment
    1 Female