BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 20860691 · Received December 6, 2024

    Report

    Report Number
    9610825-2024-00900
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    April 21, 2024
    Report Date
    March 20, 2025
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 OR SERIAL 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE LARGE VOLUME PUMP (MATERIAL # 87136051U, SERIAL # UNKNOWN, LOT UNKNOWN) WAS BEING USED TO ADMINISTER MEDICATIONS ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PUMP EXPERIENCED AIR IN LINE ALARMS THAT WERE NOT ABLE TO BE CLEARED. THE PATIENT DEVELOPED HYPOTENSION WHILE TROUBLESHOOTING THE PUMP ALARMS REQUIRING RAPID RESPONSE TEAM INTERVENTIONS, WHICH INCLUDED ADMINISTRATION OF THREE DIFFERENT VASOPRESSOR DRUGS, CALCIUM CHLORIDE AND ALBUMIN. A FEW HOURS LATER, THE AIR IN LINE ALARMS RETURNED, THE PUMP AND SET WERE CHANGED, BUT THE ALARMS RECURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376620 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN AVITUM AG 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Life Threatening| R