BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13634623 · Received February 28, 2022

    Report

    Report Number
    MW5107790
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Report Date
    February 23, 2022
    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

    PATIENT REPORTS HAS BEEN HAVING PROBLEMS WITH CADD LEGACY PUMPS AND CASSETTES SINCE THE END OF (B)(6) 2021 (EXACT DATES UNKNOWN). PUMP ISSUES ALSO REPORTED ON (B)(6) 2022 ON A SEPARATE REPORT; NO NEW INFO PROVIDED. PATIENT PROVIDED LOT NUMBERS FOR BAD CASSETTES: 15 UNOPENED CASSETTES LOT NUMBER 4173645, EXPIRATION DATE 12/20/2021; 1 CASSETTE LOT NUMBER 4213379, EXPIRATION DATE 02/12/2022 OR 02/13/2022; 1 CASSETTE LOT NUMBER 4220001, EXPIRATION DATE 02/08/2022. INFORMED PATIENT THAT WE WILL HAVE NURSE REACH OUT TO MAKE SURE SHE IS USING CASSETTES AND PUMP PROPERLY. DEFECTIVE CASSETTES WILL BE RETURNED. PATIENT DID NOT NEED ANY REPLACEMENT CASSETTES AT THIS TIME. NO FURTHER INFORMATION GIVEN. 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? NO; 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; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216010 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4213379
    1216011 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4220001
    1216012 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4173645

    Patients

    Seq Age Sex Outcome Treatment
    1 Female LEGACY PUMP MODEL 6400