BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13237724 · Received January 11, 2022

    Report

    Report Number
    MW5106611
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 2, 2021
    Report Date
    December 2, 2021
    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

    VIA SPONTANEOUS CALL, PATIENT REPORTED THAT SHE HAD TO WASTE A DOSE OF REMODULIN BECAUSE WHEN SHE WAS PUTTING MEDICINE INTO THE CASSETTE, IT DIDN'T GO INTO THE BAG WITHIN THE CASSETTE. IT WENT STRAIGHT INSIDE THE CASSETTE. ASKED IF PERHAPS THERE WAS A HOLE IN THE BAG WITHIN THE CASSETTE. PATIENT IS UNSURE. PER PATIENT, SHE HAS ENOUGH REMODULIN AND SUPPLIES TO MAKE NEW CASSETTE. PER PATIENT, FAULTY CASSETTE LOT# 4173642. ADVISED PATIENT TO NOTIFY PHARMACY IF SHE HAS ANY ISSUES WITH OTHER CASSETTES. NO OTHER INFORMATION 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 [MFR] REPLACE THE CASSETTE? NO; 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
    1546851 CASSETTE MEDI RESERVOIR SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4173642

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female