BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 8383309 · Received March 1, 2019

    Report

    Report Number
    9610825-2019-00032
    Event Type
    Injury
    Date Received
    March 1, 2019
    Report Date
    April 4, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716752
    PMA / PMN Number
    K083689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL DEVICE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    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. ADDITIONAL ATTEMPTS TO GET ADDITIONAL INFORMATION AND TO RECEIVE THE DEVICE 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 ON MEDWATCH REPORT : (B)(4). PATIENT ARRIVED IN THE SICU AFTER SURGERY AND POST-OP RECOVERY WITH THREE (3) IV INFUSIONS CONNECTED; HEPARIN (700 UNITS/HR), LACTATED RINGER (50 CC/HR), AND CARDIZEM WHICH WAS BELIEVED TO BE STOPPED. AFTER ONE PUMP ALARMED FOR AN UPSTREAM OCCLUSION, IT WAS DISCOVERED THAT THE PUMP BELIEVED TO BE INFUSING THE LR SOLUTION HAD ACTUALLY BEEN DELIVERING THE CARDIZEM AT 50 CC/HR. THE LR SOLUTION WAS DELIVERING BY GRAVITY, WITHOUT A PUMP, AND ANOTHER PUMP HAD AN LR SOLUTION PREPARED AND LOADED, BUT WAS NOT DELIVERING. HEPARIN WAS INFUSING CORRECTLY. THE CARDIZEM IV WAS IMMEDIATELY DISCONTINUED. PATIENT EXPERIENCED HR ISSUES (PAUSES, BRADYCARDIA) AND DECREASED BP. ABOUT 15 MIN AFTER CARDIZEM WAS DISCONTINUED, PATIENT CODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174340 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713050U 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R