BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CADD LEGACY

    MDR report key: 13289353 · Received January 18, 2022

    Report

    Report Number
    MW5106734
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 17, 2021
    Report Date
    December 17, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    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 FROM PATIENT CALLING TO INFORM PHARMACY THAT HER CADD LEGACY PUMP SERIAL NUMBER (B)(4) AND (B)(4) BOTH SHOWED NO DISPOSABLE, CLAMP TUBING. SHE STATED SHE KEEPS GOING BACK AND FORTH WITH THE PUMPS BUT AFTER A FEW HOURS THE MSG POPS UP AGAIN. TUBING LOT NUMBER IS 4163596. ADVISED SHE SHOULD SWITCH OUT THE TUBING AS IT COULD BE AN ISSUE WITH THE TUBING. 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? 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. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122699 PUMP CADD LEGACY PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 6400
    122700 PUMP CADD LEGACY PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 6400
    122701 CADD EXT SET SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4163596

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female