BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13995950 · Received April 1, 2022

    Report

    Report Number
    MW5108741
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 30, 2022
    Report Date
    March 31, 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

    PER SPONTANEOUS CALL FROM THE PATIENT SHE HAD A MALFUNCTIONING CASSETTE FROM LOT NUMBER 4192063. ON (B)(6) 2022 SHE CHANGED HER CASSETTE AND GOT A NO DISPOSABLE PUMP WON'T RUN ALARM. SHE SWITCHED THE CASSETTE TO HER BACK UP PUMP AND GOT THE SAME ALARM. SHE THEN MIXED ANOTHER NEW CASSETTE AND WAS ABLE TO RESUME HER INFUSION WITH NO ISSUE. SHE DOES NOT HAVE THE CASSETTE TO RETURN FOR INVESTIGATION. AN ORDER FOR MORE CASSETTES WAS ALREADY SHIPPED AND WILL ARRIVE TO THE PATIENT TODAY. NO HARM WAS DONE TO THE PATIENT. THIS IS A LIFE-SUSTAINING INFUSION. NO FURTHER INFORMATION 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? NO; 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; 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
    96092 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. NA 4192063

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female