BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 15412826 · Received September 12, 2022

    Report

    Report Number
    MW5111995
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 8, 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

    SPONTANEOUS CALL FROM PT SPOUSE, ON (B)(6) 2022 CASSETTE CHANGE, A CASSETTE READ "UNABLE TO PUMP" ON BOTH PT PUMPS. SHE SWITCHED CASSETTES AND WAS ABLE TO CONTINUE INFUSION. ALSO, PT SPOUSE REPORTED SHE IS USING 8ML OF REMODULIN 2.5MG W/ 92ML OF DILUENT EACH MIX INSTEAD OF PRESCRIBED 7ML OF REMODULIN 2.5MG/ML W/ 93ML DILUENT TO EQUAL A DOSE OF 80NKM. CURRENT DOSE CALCULATED TO BE 92NKM. MD INFORMED. NO SIDE EFFECTS. NO OTHER INFO KNOWN. 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 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; IS THE INFUSION LIFE SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2674864 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male PUMP.| REMODULIN.