BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT

    MDR report key: 8235831 · Received January 10, 2019

    Report

    Report Number
    9610825-2019-00001
    Event Type
    Death
    Date Received
    January 10, 2019
    Date of Event
    January 16, 2017
    Report Date
    October 28, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K142596
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). COPIES OF THE DEVICE HISTORY LOGS WERE RECEIVED ON 09.OCT.2020. THE LOGS WERE REVIEWED FOR THE REPORTED DATE OF THE EVENT, (B)(6) 2017, HOWEVER THE OLDEST ENTRY ON THE DEVICE HISTORY LOG WAS FROM (B)(6) 2017. THE PUMP HAD BEEN PUT BACK INTO USE, AND THE DEVICE HISTORY LOG WILL ONLY STORE A CERTAIN NUMBER OF ENTRIES BEFORE OVERWRITING THE OLDEST ENTRIES. AS A RESULT, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY LOG SHOWS THAT THERE WERE 61 DAYS OF OPERATION BETWEEN 17 FEB 2017 AND 30 MAY 2018 (AFTER THE (B)(6) 2017 EVENT). THERE WERE NO OTHER REPORTS OF INCIDENT OR ISSUE WITH THE DEVICE. THE DATA THEREFORE DOES NOT SUPPORT THE CONCLUSION THAT THE DEVICE WAS DEFECTIVE AS THE ACCOUNT CONTINUED TO USE THE INFUSOMAT SPACE PUMP AFTER THE REPORTED INCIDENT WITH NO FURTHER COMPLAINTS RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ATTEMPTS TO GET ADDITIONAL INFORMATION ON THE INCIDENT AND TO GET THE DEVICE INVOLVED IN THE REPORTED INCIDENT RETURNED FOR EVALUATION ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED: PATIENT COMPLAINED OF FACIAL NUMBNESS AND UNSTEADINESS. BLOOD PRESSURE WAS MEASURED AT 220/140 WITH A HEART RATE OF 82. THE PATIENT WAS NEUROLOGICALLY INTACT WITH CLEAR SPEECH AND DIMINISHING SYMPTOMS. NO REPORT OF HEADACHE, CHEST PAIN, OR TROUBLE BREATHING. A CT AND EKG WERE TAKEN AND DID NOT SHOW ANY ACUTE ABNORMALITIES OR PROCESSES. THE PATIENT WAS STARTED ON A 5MCG NITROGLYCERIN DRIP IV IN 250ML AT A 5MCG PER MINUTE RATE OVER 8 HOURS VIA AN IV PUMP. AFTER 13 MINUTES THE PATIENT'S BLOOD PRESSURE DROPPED TO 113/67 WITH A HEART RATE OF 68. AFTER ANOTHER 3 MINUTES THE PATIENT BECAME DIAPHORETIC AND BEGAN VOMITING WITH ALTERED COGNITION, SLURRED SPEECH, AND LOSS OF GRIP ON HIS RIGHT SIDE. AT THIS POINT THE INFUSION WAS STOPPED, AND THE PATIENT WAS GIVEN A DOSE OF ATIVAN. THE PATIENT RECEIVED A 100CC BOLUS OF NITROGLYCERIN IN ABOUT 20 MINUTES, INSTEAD OF OVER 8 HOURS AS ORDERED BY THE PHYSICIAN. THE PATIENT CONTINUED TO DECLINE AND EVENTUALLY HAD TO BE INTUBATED, AND TRANSFERRED TO AN ICU AT ANOTHER FACILITY. AT THIS TIME, AN MRI WAS PERFORMED AND IT REVEALED MULTIPLE INFARCTS. SUPPORTIVE CARE WAS GIVEN, BUT THE PATIENT DID NOT SHOW SIGNS OF IMPROVEMENT. THE PATIENT DIED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27446 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death