BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 16026418 · Received December 20, 2022

    Report

    Report Number
    MW5113904
    Event Type
    Injury
    Date Received
    December 20, 2022
    Report Date
    December 15, 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

    PATIENT REPORTED OF BEING A BIT MORE SHORT OF BREATH, BUT SHE IS ON OXYGEN. ADVISED PATIENT TO GO TO THE ER, IF SHORTNESS OF BREATH INCREASES, BUT PATIENT STATED SHE WILL BE FINE. RECALLED CASSETTES PATIENT HAS ON HAND ARE LOT NUMBERS: 4257001, 4329610, 4163261(EXPIRATION DATES UNKNOWN), UNKNOWN WHAT LOT PATIENT IS CURRENTLY INFUSING WITH, NOR IF THE CASSETTE IS CONTRIBUTING TO SIDE EFFECTS. PHARMACY TO SEND REPLACEMENT CASSETTES. UNKNOWN IF MD IS AWARE OF SIDE EFFECTS. PRODUCT LOT NUMBER AND EXPIRATION DATE WERE SYSTEMATICALLY RETRIEVED FROM THE DISPENSING SYSTEM. PUMP RETURN TRACKING INFO IS NOT APPLICABLE TO EVENT. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNK. POSITION OF PUMP WHEN ALARM OCCURRED IS NOT APPLICABLE. NO ADD'L INFO IS AVAILABLE AT THIS TIME. 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? UNK; IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? UNK; DID WE [MFR] REPLACE THE PRODUCT? YES; DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? UNK. WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR THERAPY? YES; REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613603 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4329610
    1613604 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4163261
    1613605 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK 4257101

    Patients

    Seq Age Sex Outcome Treatment
    1 Female VELETRI