BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19467072 · Received June 5, 2024

    Report

    Report Number
    2523676-2024-00591
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Report Date
    November 12, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964186080
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE OR LOT NUMBER WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: MY NAME IS MICHAEL LEBLANC, AND I AM A PHARMACY SUPERVISOR AT (B)(6) NY. I AM CONTACTING YOU TODAY AS WE HAVE HAD MULTIPLE INSTANCES OF A TUBING SET USED FOR A 24 HOUR EXTENDED INFUSION OF METHOTREXATE STARTING TO LEAK AT THE LOWEST Y-SITE ANYWHERE FROM 15 HOURS INTO THE INFUSION TO JUST PRIOR TO END OF INFUSION. PREVIOUSLY LAST WEEK (B)(6) 2024) I SUBMITTED AN UNUSED SET AND PHOTOS OF A FAILED SET THAT WE WERE ABLE TO RECOVER. THIS WEEK WE HAD YET ANOTHER TUBING SET FAIL AT THE Y-SITE WHERE LUCKILY IT WAS JUST THE IV FLUID, WHEREAS PREVIOUS INSTANCES THE METHOTREXATE HAD COME THROUGH. I HAVE THIS MOST RECENT SET AND WOULD LIKE TO SUBMIT IT FOR REVIEW OF POTENTIAL PROBLEMS AS AN ACTUAL FAILED LINE VS AN UNUSED SET. PLEASE LET ME KNOW WHAT STEPS I CAN TAKE TO ENSURE PROPER AND SAFE DELIVERY OF THIS SET TO BBRAUN FOR EVALUATION. BELOW IS THE FORWARDED CONVERSATIONS FROM LAST WEEK WITH OUR REP CHIP AND THE ADDITIONAL CONVERSATION THIS AFTERNOON REGARDING NEWEST ISSUE. NO INJURY REPROTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171131 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 04046964186080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown