BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXT SET

    MDR report key: 13660818 · Received March 2, 2022

    Report

    Report Number
    MW5107864
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 26, 2022
    Report Date
    February 26, 2022
    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. PATIENT REPORTING THAT THEY ARE CURRENTLY TRYING TO PRIME TUBING [LOT NUMBER 4220038] AND KEEPS GETTING "HIGH PRESSURE" ALARM ON PUMP (SERIAL NUMBER (B)(4)). PATIENT WAS ABLE TO PRIME TUBING WITHOUT THE EXTENSION SET ATTACHED. PATIENT CHANGED EXTENSION SET AND WAS ABLE PRIME TUBING SUCCESSFULLY. THIS IS NOT A PUMP ISSUE. PATIENT WILL BE SENT REPLACEMENT EXTENSION SETS. DID THE PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL TUBING AVAILABLE FOR INVESTIGATION? NO; DID WE [MFR] REPLACE THE TUBING? PT HAS EXTRA BUT WILL RECEIVE NEW TUBING EVERY WEEK. DID THE PT HAVE ADD'L TUBING THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2632810 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4220038

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female PUMP