BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 10747579 · Received October 27, 2020

    Report

    Report Number
    MW5097480
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    January 1, 2020
    Report Date
    October 17, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT STATING HER CADD EXTENSION SET IS LEAKING JUST A TINY BIT AROUND THE ANTISIPHON VALVE. STATES SHE HAS HAD THIS ISSUE 2 OR 3 TIMES IN THE LAST FEW MONTHS. ADVISED TO CHANGE TUBING. LOT NUMBER 3983998. NO LAPSE IN INFUSION OR SIDE EFFECTS DUE TO MALFUNCTION. PATIENT HAS BACKUP SUPPLIES. INFUSION IS LIFE-SUSTAINING. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? NO. DID WE [MFR] REPLACE DEVICE? YES. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES. IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED? ONGOING? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209331 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. UNK 3983998
    1209355 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3983998
    1209356 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3983998

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR