BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXT SET

    MDR report key: 10606117 · Received September 29, 2020

    Report

    Report Number
    MW5096968
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Report Date
    September 3, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT SHE HAS BEEN HAVING TROUBLE WITH TUBING LATELY. IT DOESN'T WANT TO STAY CONNECTED TO CASSETTE OR THE FILTER LEAKS {LOT 3931784), WHICH IS WHY SHE HAS TO REQUEST EXTRA TUBING EACH SHIPMENT. NO OTHER INFORMATION OR DATES KNOWN. DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED? ONGOING? RESOLVED. DID THE PRODUCT FAULT OCCUR WHILE IN USE WITH A PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES; DID WE [MFR] REPLACE DEVICE? NO, PT HAS EXTRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066345 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3931784

    Patients

    Seq Age Sex Outcome Treatment
    1