BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13289916 · Received January 18, 2022

    Report

    Report Number
    MW5106759
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    November 1, 2021
    Report Date
    December 20, 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

    DURING SPONTANEOUS CALL WITH THE PATIENT, PER PT, PT STATES THAT SHE RECEIVED #60 CASSETTES OF THE BAD BATCH OF CASSETTES & HAVE BEEN USING MORE THAN 1 CASSETTE PER DAY BECAUSE OF THIS. PT ALSO STATES SHE HAS BEEN USING MORE THAN 1 VIAL OF VELETRI PER DAY WHEN THE CASSETTE IS BAD. PT STATES LOT NUMBER OF BAD CASSETTES: 4173645. PATIENT STATES SHE DOES HAVE THE CASSETTES ON HAND TO RETURN IF NEEDED. PHARMACY WILL BE REPLACING CASSETTES AND SENDING 2 NEW CADD LEGACY PUMPS JUST IN CASE FOR DELIVERY ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] REPLACE THE CASSETTE? YES; DID THE PT HAVE ADD'L CASSETTES 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
    122708 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4173645

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female