BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASSETTE MEDICATION RESERVOIR

    MDR report key: 16026255 · Received December 20, 2022

    Report

    Report Number
    MW5113900
    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 REPORTS SHE HAS MULTIPLE CASSETTES AFFECTED BY RECALL. LOT NUMBER'S: 4315909: TWO CASSETTES, 4329617: THREE CASSETTES, 4042844: TWO CASSETTES (EXPIRATION DATES NOT PROVIDED). PATIENT COMPLAINED OF INCREASED SHORTNESS OF BREATH IN THE PAST FEW DAYS. SHE WILL MAKE A NEW MIX WHEN NEW CASSETTES ARRIVE TOMORROW MORNING. UNSPECIFIED WHICH LOT NUMBER PATIENT IS CURRENTLY INFUSING WITH. NO OTHER INFORMATION KNOWN. PUMP RETURN TRACKING INFORMATION IS NOT APPLICABLE TO EVENT. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF PUMP WHEN ALARM OCCURRED IS NOT APPLICABLE. NO ADDITIONAL INFORMATION 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? NO; IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] REPLACE THE PRODUCT? YES; DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? NO; PT WAS SHIPPED NEW CASSETTES TO SWITCH TO TOMORROW MORNING. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613592 CASSETTE MEDICATION RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK 4315909
    1613593 CASSETTE MEDICATION RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4315909
    1613594 CASSETTE MEDICATION RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4042844
    1613595 CASSETTE MEDICATION RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4329617
    1613596 CASSETTE MEDICATION RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4329617
    1613597 CASSETTE MEDICATION RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4329617
    1613598 CASSETTE MEDICATION RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4042844

    Patients

    Seq Age Sex Outcome Treatment
    1 Female