BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXT SET TUBING

    MDR report key: 13290082 · Received January 18, 2022

    Report

    Report Number
    MW5106771
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Report Date
    December 17, 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. PATIENT'S WIFE REPORTING PUMP GIVING ERROR 'NO DISPOSABLE TUBING FOUND'. TUBING LOT NUNT.ER 4192050. ADVISED TO CHANGE OUT TUBING. THIS IS PC COMPLAINT FOR TUBING ONLY. (B)(6). 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? YES. DID WE [MFR] REPLACE DEVICE? NO. 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? ONGOING. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122721 CADD EXT SET TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 4192050

    Patients

    Seq Age Sex Outcome Treatment
    1 Male