BEUDAMED
    FDA Adverse Event Death Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 18702998 · Received February 13, 2024

    Report

    Report Number
    MW5151554
    Event Type
    Death
    Date Received
    February 13, 2024
    Date of Event
    February 6, 2024
    Report Date
    February 7, 2024
    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

    PATIENT'S SPOUSE REPORTED PATIENT PASSED AWAY ON (B)(6) 2024. WHEN INVESTIGATING THE PATIENT'S PUMP AND CASSETTE SHE WAS UTILIZING THE DAY OF PASSING, HE DISCOVERED THAT THE PUMP SHOWED 98 ML HAD BEEN GIVEN. THIS DID NOT ALIGN WITH WHAT WAS SEEN IN THE BLADDER OF THE CASSETTE (HE STATED APPROXIMATELY HALF FULL). HE ALSO ADVISED THAT THERE WERE AIR BUBBLES PRESENT IN THE BLADDER AS WELL. SPOUSE ADVISED HE'S ADAMANT ABOUT ENSURING THERE ARE NO AIR BUBBLES PRESENT WHEN PREPARING THE CASSETTES. THE PATIENT'S DEATH WAS RELATIVELY UNEXPECTED AND TOOK PLACE AT HOME. SPOUSE GAVE NO INDICATION THAT THERE WERE ALERTS DURING THE TWO DAYS LEADING UP TO THE PATIENT'S DEATH. LAST CASSETTE WAS PLACED ON (B)(6) 2024. PUMP SERIAL NUMBER: (B)(6) /NO DUE DATE. SPOUSE HAS PUMP/CASSETTE ON HAND FOR RETURN. PHARMACY NOTIFIED MD OFFICE. UNKNOWN IF CASSETTE/PUMP OR BOTH CONTRIBUTED TO EVENT. NO LOT NUMBER/EXPIRATION DATE FOR CASSETTE PROVIDED. NO FURTHER INFORMATION. DATE OF LAST DOSE UNKNOWN. CAUSE OF DEATH NOT PROVIDED. IV REMODULIN PATIENT. PUMP RETURN TRACKING INFORMATION IS NOT APPLICABLE TO EVENT. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF PUMP WHEN ALARM OCCURRED IS NOT APPLICABLE. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. 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? YES. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES. DID WE REPLACE THE DEVICE? NOT APPLICABLE. 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? NOT APPLICABLE. IS THE INFUSION LIFE-SUSTAINING? YES. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. REFERENCE REPORT: MW5151553.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157756 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death OPSUMIT.| PUMP CADD LEGACY.| REMODULIN MDV.