BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT®

    MDR report key: 20863003 · Received December 6, 2024

    Report

    Report Number
    2523676-2024-01063
    Event Type
    Death
    Date Received
    December 6, 2024
    Date of Event
    April 29, 2024
    Report Date
    January 16, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    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 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.

    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. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. 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

    IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSION SET (MATERIAL UNKNOWN, LOT UNKNOWN) WAS BEING USED TO ADMINISTER NOREPINEPHRINE (NOREPI) AND EPINEPHRINE (EPI) ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, AFTER PATIENT HAD CODED IN THE OPERATING ROOM (OR) SEVERAL TIMES, WE WERE TRANSFERRING PATIENT TO BED IN ORDER TO TRANSPORT TO INTENSIVE CARE UNIT (ICU). AIR IN LINE ALARM SOUNDED FOR BOTH EPI AND NOREPI INFUSIONS. PATIENT TOO UNSTABLE TO DISCONNECT LINE. PULLED AIR OUT OF BOTH LINES WITH SYRINGES AND RESUMED INFUSIONS. BOTH INFUSIONS KEPT ALARMING AIR IN LINE DESPITE HAVING CORRECTED THE PROBLEM. THERE WAS NO WAY TO CONTINUE THE INFUSIONS. BOLUSED PATIENT INSTEAD WITH VASOPRESSORS. EVENTUALLY GOT THE EPI DRIP TO WORK BUT THE NOREPI DRIP NEVER WORKED AND HAD TO WAIT FOR ANOTHER PUMP AND LINE SETUP TO ARRIVE, MEANWHILE BOLUSING PATIENT. PATIENT ARRESTED MULTIPLE TIMES UPON ARRIVAL TO ICU DURING PUMP MALFUNCTION, BUT PATIENT WAS DOING SO PRIOR TO MALFUNCTIONING PUMPS. DEATH OF PATIENT OCCURRED, NOT DUE TO MALFUNCTIONING PUMPS BUT MADE THE SITUATION A LOT MORE DIFFICULT. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120415 INFUSOMAT® SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Death| R| L