BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 14885316 · Received June 30, 2022

    Report

    Report Number
    MW5110632
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 28, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT'S SPOUSE REPORTED THAT PT STARTED USING OXYGEN ON (B)(6) 2022. SHE ALSO NOTED THERE WAS AN ISSUE WITH ONE OF THE CASSETTES THE OTHER DAY. SHE MIXED A NEW CASSETTE AND RESUMED INFUSION. SPOUSE DID NOT HAVE LOT OR EXPIRATION INFORMATION. PHOTOGRAPHS WERE NOT PROVIDED. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNKNOWN. THIS IS A CONTINUOUS INFUSION. PUMP RETURN TRACKING INFORMATION IS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. IF ANY ADDITIONAL INFORMATION IS RECEIVED IT WILL BE PROVIDED ON A SEPARATE REPORT PRODUCT LOT NUMBER AND EXPIRATION DATE WERE SYSTEMATICALLY RETRIEVED FROM THE DISPENSING SYSTEM. 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? PT HAD BACKUPS; 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
    397886 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male