BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 12598347 · Received October 7, 2021

    Report

    Report Number
    MW5104480
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 14, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS REPORT FROM PATIENT WHO REPORTED SECOND FAULTY CASSETTE FROM THE SAME PREMIX BATCH THAT WAS MIXED ON 04/05/2021, LOT NUMBER 4042844. SAME ERROR MESSAGE OF 'NO DISPOSABLE' FOUND ON BOTH PUMPS. PATIENT STATED SHE ATTACHED THIS CASSETTE ON (B)(6) 2021 AND GOT ERROR MESSAGE ON (B)(6) 2021 WITH 61.4 ML LEFT IN THE CASSETTE. PATIENT WILL QUARANTINE THIS CASSETTE IN CASE MANUFACTURER REQUESTS IT FOR INVESTIGATION. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; DID WE REPLACE DEVICE? NO; DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492838 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK 4042844
    1492839 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4042844

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR