BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13591855 · Received February 23, 2022

    Report

    Report Number
    MW5107653
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Report Date
    February 19, 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 CALLED WITH PUMP MALFUNCTION ISSUE. LOT 4192053. PATIENT WAS RECEIVING NO DISPOSABLE, PUMP WON'T RUN ERROR. ADVISED PT TO CHANGE CASSETTES. ISSUE APPEARS TO BE A FAULTY CASSETTE AS NEW CASSETTE WORKED FINE. 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, PT REPLACED WITH CURRENT CASSETTE ON HAND; 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.

    Description of Event or Problem · 0

    PATIENT CALLED WITH PUMP MALFUNCTION ISSUE. LOT 4192053. PATIENT WAS RECEIVING NO DISPOSABLE, PUMP WON'T RUN ERROR. ADVISED PT TO CHANGE CASSETTES. ISSUE APPEARS TO BE A FAULTY CASSETTE AS NEW CASSETTE WORKED FINE. 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, PT REPLACED WITH CURRENT CASSETTE ON HAND; 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
    1863081 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192053

    Patients

    Seq Age Sex Outcome Treatment
    1 Female