BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19472176 · Received June 5, 2024

    Report

    Report Number
    2523676-2024-00586
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 5, 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
    CA, 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). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. 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: EVENT 4. BRIEF INQUIRY DESCRIPTION. EXCESSIVE AIR IN LINE AND DOWNSTREAM OCCLUSION ALARMS. DETAILED INQUIRY DESCRIPTION ON CALL WITH THE CUSTOMER 5.23.24, BIOMED AND NURSING C/O EXCESSIVE AIL AND DOWNSTREAM OCCLUSION ALARMS AFTER CONVERTING FROM SWG PUMPS TO NEW SWU (U17) PUMPS. NOTES FROM CALL ATTACHED. 4 PUMPS SENT DOWN TO BIOMED, 2 RELEASED BACK IN TO SERVICE 2 REMAIN. ADAM ARMSTRONG WILL TRY TO COLLECT THOSE 2 REMAINING PUMPS FOR TESTING. · REPORTED AN INCREASE IN AIRLINE FAILURE MESSAGE ON IV PUMP NOTED 4 SERVICE CALLS WITHIN 2 WEEKS · TWO WERE CLEANED PER PROTOCOL, RETURNED TO SERVICE · TWO REMAIN IN BIOMED, NOT REPLACED RECOMMENDED IF "OLD TUBING" IS THE CULPRIT, RECOMMENDED TO PURSUE THIS FIRST. VENDOR ASKED FOR A SAMPLE AND ERROR TIMESTAMPS. BBRAUN TECHNICAL STAFF TO CONFIRM VIEW OF RECENT ERRORS AT MURRIETA. FOLLOWING THAT, AIR LIMIT MAY NEED TO BE ADJUSTED DESCRIPTION OF THE PATIENT EVENT EXCESSIVE AIR IN LINE ALARMS WITH PUMP CHANGE AND DOWNSTREAM OCCLUSION THAT DELAYED PATIENT CARE. NO PUMP OR TUBING INFO AVAILABLE AT THIS TIME NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089519 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 04046964186080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown