BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5450905 · Received February 22, 2016

    Report

    Report Number
    9610825-2016-00062
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    January 1, 2016
    Report Date
    February 10, 2016
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT (B)(4). IN A FOLLOW UP WITH THE FACILITY, THE REPORTER STATED THAT THE FACILITY HAD RECENTLY CHANGED TO THE SPACE PUMP PRODUCTS AND WERE USED TO USING A COMPETITOR'S PUMP. SHE CONFIRMED THAT THERE WAS "NO EXTRAVASATIONS, NO CONSULTATIONS, NO MEDICAL INTERVENTION OTHER THAN SWELLING AND THE NURSES HAD TO RESTART THE INFUSIONS. SHE STATED THAT BECAUSE THEY USE TO A DIFFERENT MANUFACTURER'S PUMP, THEY SET THE OCCLUSION LEVEL AT '4' BELIEVING IT INDICATED '4' PSI, AND THAT THIS WAS ERRONEOUS ON THEIR PART AS IT WAS "APPLES AND ORANGES' FROM WHAT THEY WERE USED TO. THE REPORTER STATED THAT SHE DID NOT KNOW THE SERIAL NUMBERS OF THE PUMPS AT THE TIME. THE ACTUAL DEVICE HAS NOT BEEN RECEIVED YET AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT (B)(4) IN A FOLLOW UP WITH THE FACILITY, THE REPORTER STATED THAT THE FACILITY HAD RECENTLY CHANGED TO THE SPACE PUMPS AND WERE USED TO USING A COMPETITOR'S PUMPS. SHE CONFIRMED THAT THERE WAS "NO EXTRAVASATIONS, NO CONSULTATIONS, NO MEDICAL INTERVENTION OTHER THAN SWELLING AND THE NURSES HAD TO RESTART THE INFUSIONS. SHE ALSO STATED THAT BECAUSE THEY USED A COMPETITOR'S AND SET THE OCCLUSION LEVEL AT '4' BELIEVING IT INDICATED '4' PSI, AND THAT THIS WAS ERRONEOUS ON THEIR PART AS IT WAS "APPLES AND ORANGES' FROM WHAT THEY WERE USED TO. AS THE ACTUAL DEVICE OR LOGS WERE NOT RETURNED FOR EVALUATION, FURTHER EVALUATION WAS NOT POSSIBLE HOWEVER, THIS EVENT IS ATTRIBUTED TO HUMAN FACTORS AND ADDITIONAL SUPPORT HAS BEEN PROVIDED TO THE FACILITY.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: (B)(6) 2016, (B)(6) MALE, (B)(6), 1,000ML OF 5% DEXTROSE WITH 1/2 NS WITH 20MEQ OF KCL INFUSING AT 36 ML/HR. INFORMATION FROM NURSING NOTES: "IV CHECKED AT 9:30AM, NO SWELLING, AT 9:58 AM SITE EDEMATOUS, NO EXTRAVASATION, NO TISSUE DAMAGE, IV REMOVED AND RESTARTED RIGHT HAND" ORIGINAL IV SITE: LEFT ANTECUBITAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108671 INFUSOMAT SPACE INFUSION PUMP FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other