BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 15320786 · Received August 29, 2022

    Report

    Report Number
    MW5111766
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 19, 2022
    Report Date
    August 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

    SPONTANEOUS INBOUND CALL FROM PT STATING HER CURRENT CASSETTE WAS NOT WORKING IN EITHER PUMP. CASSETTE HAS APPROXIMATELY 17 ML LEFT AND WAS MIXED ON (B)(6) 2022 (48 HOUR CHANGES; WOULD BE CHANGING LATER TONIGHT). PUMP ALARMS GO OFF BUT NO ERROR MESSAGE. PATIENT INVESTIGATED WHETHER OR NOT THE BLADDER OF THE CASSETTE WAS PROTRUDING. SHE STATED IT WAS SLIGHTLY AND PUSHED IT BACK IN WITH A DULL OBJECT. REATTACHED TO PUMP BUT SAME WARNING. PATIENT ADVISED TO MIX A NEW CASSETTE. PATIENT WILL DRAIN AND HOLD ONTO CASSETTE FOR RETURN/INVESTIGATION. SHE COULD NOT LOCATE SERIAL NUMBER/LOT NUMBER. PATIENT STATED THIS OCCURRED ONE WEEK AGO AS WELL WHEN SHE WAS 1/2 WAY THROUGH A CASSETTE. PATIENT DID NOT REPORT THAT CASSETTE ISSUE AND DID DISCARD IT. PATIENT TO CALL BACK WITH ANY ADDITIONAL PROBLEMS. NO OTHER DATES OR INFORMATION PROVIDED. NO ADD'L INFO DETAILS OR DATES ARE AVAILABLE. PUMP RETURN TRACKING INFO IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION SETFLOW RATE AND VOLUME DELIVERED ARE UNK, POSITION OF THE PUMP. 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? NO, DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? NA; IS THE INFUSION LIFE SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? PT WAS GOING TO MIX A NEW CASSETTE AND CALL BACK IF THERE CONTINUED TO BE ANY PROBLEMS, RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385624 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    385625 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female