BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5701644 · Received June 6, 2016

    Report

    Report Number
    9610825-2016-00336
    Event Type
    Death
    Date Received
    June 6, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 16, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC.(THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). IN A FOLLOW UP WITH THE FACILITY, THE REPORTER STATED THAT THE PATIENT DID EXPIRE. UPON CONFERRING WITH THE FAMILY, CARE WAS DEESCALATED AFTER CODE. THE REPORTER STATED THAT THE PATIENT WAS TRANSFERRED TO THEIR LONG TERM SPECIALTY CARE ON (B)(6) 2016 WITH DIAGNOSIS OSTEOMYELITIS WITH EPIDURAL ABSCESS AND MITRAL VALVE ENDOCARDITIS. THE REPORTER DID NOT HAVE ANY INFORMATION ON ANY PREVIOUS PROCEDURES OR LENGTH OF HOSPITAL STAY. PATIENT WAS TRANSFERRED ON VASOPRESSORS AND WAS ON THEM WHOLE LENGTH OF STAY. PHYSICIAN SPOKE WITH FAMILY AT TIME OF INCIDENT AND IT WAS DECIDED TO MAKE PATIENT DNR WITH COMFORT MEASURES AS HER CONDITION HAD BEEN DETERIORATING FOR THE ENTIRE STAY. THE REPORTER ALSO STATED THAT 250 ML OF NOREPINEPHRINE WAS INFUSED IN UNDER 30 MINUTES CONCENTRATION WAS 4MG IN 250 ML TITRATING DRUG BELIEVED WAS GIVING 6 TO 7 MIC/KG FOR 150 POUND PATIENT, FEMALE. THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE PUMP'S OPERATIONAL LOG WAS REVIEWED AND THERE WERE NO INDICATION THAT THE PUMP MALFUNCTIONED. BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PUMP. WITHOUT THE ACTUAL PUMP TO EVALUATE NO ROOT CAUSE COULD BE DETERMINED. IF THE PUMP AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: REPORTS OVER INFUSION. OCCURRED (B)(6) 2016. DRUG WAS NOREPINEPHRINE, CONCENTRATION 4 MG IN 250 ML. NOT SURE ON RATE ORDER RATE INFUSED, BUT DOES KNOW A SECOND BAG WAS HUNG. PATIENT DID HAVE RESPIRATORY AND CARDIAC CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355152 INFUSOMAT SPACE INFUSOMAT PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R