BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT

    MDR report key: 11222475 · Received January 25, 2021

    Report

    Report Number
    2532083-2021-00002
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    January 12, 2021
    Report Date
    April 27, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4).

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: IN GENERAL TERMS, THIS PATIENT WAS A CODE 99 AS SHE WENT INTO V-TACH AND WAS PULSELESS ON 1/12 . MED HX REMARKABLE FOR CURRENT MI, HX OF STROKE. SHE WAS RESUSCITATED AND PLACED ON A VENTILATOR. JUST AFTER THE CODE IT WAS DISCOVERED THAT THE 250ML BAG OF HEPARIN 100UNITS/ML WAS EMPTY. THE BAG HAD BEEN HUNG 2-3 HOURS PRIOR TO THE CODE. IT WAS DETERMINED POST CODE THAT THE PATIENT PTT'S WERE ELEVATED. LABS WERE FOLLOWED AND LATER THAT DAY THE PTT'S CAME DOWN INTO NORMAL RANGE. SHE DID NOT APPARENTLY HAVE ANY BLEEDING EPISODES OF ANY KIND. THE REPORTS THAT PHARMACY CAN SEE IN DOSE TRAC SHOWED THAT THE HEPARIN WAS PROGRAMMED CORRECTLY TO INFUSE AT 8ML (800 UNITS/HR). THAT SAME PUMP WAS USED TO INFUSE A 1000 ML BOLUS OF 0.9% SALINE DURING THE CODE(990ML/HR). LATER IN THE SAME DAY THIS PUMP WAS USED TO INFUSE AMIODARONE IV. I HAD THE NURSE REMOVE THIS PUMP FROM PATIENT SO THAT WE COULD HAVE IT CHECKED OUT. THE OTHER PUMP HAD BEEN USED TO INFUSE FENTANYL(POST CODE), ZOSYN 50ML INTERMITTENTLY Q8H, AND SALINE AT 80 ML/HR (PER PUMP REPORT) TWO PUMPS WERE IN USE AT THE TIME AN ADVERSE EVENT OCCURRED. THIS REPORT IS FOR THE PUMP THAT WAS USED TO ADMINISTER THE HEPARIN. IMPORTER REPORT 2532083-2021-00001 IS BEING FILED FOR THE PUMP DELIVERING THE FENTANYL, ZOSYN, AND SALINE. THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: IN GENERAL TERMS, THIS PATIENT WAS A CODE 99 AS SHE WENT INTO V-TACH AND WAS PULSELESS ON 1/12 . MED HX REMARKABLE FOR CURRENT MI, HX OF STROKE. SHE WAS RESUSCITATED AND PLACED ON A VENTILATOR. JUST AFTER THE CODE IT WAS DISCOVERED THAT THE 250ML BAG OF HEPARIN 100UNITS/ML WAS EMPTY. THE BAG HAD BEEN HUNG 2-3 HOURS PRIOR TO THE CODE. IT WAS DETERMINED POST CODE THAT THE PATIENT PTT'S WERE ELEVATED. LABS WERE FOLLOWED AND LATER THAT DAY THE PTT'S CAME DOWN INTO NORMAL RANGE. SHE DID NOT APPARENTLY HAVE ANY BLEEDING EPISODES OF ANY KIND. THE REPORTS THAT PHARMACY CAN SEE IN DOSE TRAC SHOWED THAT THE HEPARIN WAS PROGRAMMED CORRECTLY TO INFUSE AT 8ML (800 UNITS/HR). THAT SAME PUMP WAS USED TO INFUSE A 1000 ML BOLUS OF 0.9% SALINE DURING THE CODE(990ML/HR). LATER IN THE SAME DAY THIS PUMP WAS USED TO INFUSE AMIODARONE IV. I HAD THE NURSE REMOVE THIS PUMP FROM PATIENT SO THAT WE COULD HAVE IT CHECKED OUT. THE OTHER PUMP HAD BEEN USED TO INFUSE FENTANYL(POST CODE), ZOSYN 50ML INTERMITTENTLY Q8H, AND SALINE AT 80 ML/HR (PER PUMP REPORT) TWO PUMPS WERE IN USE AT THE TIME AN ADVERSE EVENT OCCURRED. THIS REPORT IS FOR THE PUMP THAT WAS USED TO ADMINISTER THE HEPARIN. IMPORTER REPORT (B)(4) IS BEING FILED FOR THE PUMP DELIVERING THE FENTANYL, ZOSYN, AND SALINE. THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118004 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1