BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 5755134 · Received June 28, 2016

    Report

    Report Number
    9610825-2016-00406
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 7, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 INC. INTERNAL REPORT NUMBER (B)(4). THE OPERATIONS LOG FOR SERIAL NUMBER (B)(4) WAS REVIEWED. THE OPERATIONS LOG SHOWS THAT A VANCOMYCIN INFUSION WAS PROGRAMMED WITH A TOTAL DOSE OF 12.938 MG/KGKG AND A DOSE RATE OF 12.930 MG/KGKG/HR AT 08:11 P.M. ON 17.MAY.2016 USING A BD 10 ML PLASTIPAK SYRINGE. THE INFUSION WAS STARTED WITH A VOLUME TO BE INFUSED OF 9.60 ML AT A RATE OF 9.60 ML/HR. AT 09:02 P.M. THE PUMP ISSUED A "SYRINGE NEAR EMPTY" ALARM AND STOPPED INFUSING AT 09:05 P.M. WITH A "SYRINGE EMPTY" ALARM AND A TOTAL VOLUME DELIVERED OF 8.69 ML. THE VOLUME DELIVERED WAS WITHIN THE +/- 2.5% ACCURACY SPECIFICATION. PER THE PRODUCT INSTRUCTIONS FOR USE, DUE TO VARYING SYRINGE TOLERANCES OF SYRINGES FROM OTHER MANUFACTURERS, SOME FLUID MAY BE LEFT INSIDE THE SYRINGE. RESTARTING THE INFUSION LEADS TO A COMPLETE DEPLETION OF THE SYRINGE AND SHUT-OFF VIA THE PRESSURE SENSOR. THERE IS NO INDICATION FROM THE LOGS THAT USER RESTARTED THE INFUSION TO ACHIEVE FULL DEPLETION. BASED ON THE INFORMATION REPORTED BY THE USER AND THE DATA FROM THE OPERATIONS LOG THE PUMP PERFORMED WITHIN SPECIFICATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED SERIAL NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. BECAUSE THERE WERE NO ADVERSE TRENDS, NO ADDITIONAL ACTIONS ARE BEING TAKEN AT THIS TIME. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    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 INC. INTERNAL REPORT# (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE INSPECTION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY. CUSTOMER REPORTS: BIOMED STATING THE BD 10 ML SYRINGE VALIDATED FOR USE WITH THE SPACE PERFUSOR PUMP, ARE EXPERIENCING IN THE NICU THAT THE SYRINGE IS UNDER INFUSING. IT WILL LEAVE 0.1-0.2 ML IN SYRINGE. UPON REQUESTING FURTHER INFORMATION TO END USER, RESPONSE WAS AS FOLLOWS: DRUG: VANCOMYCIN, RATE: 9.6ML/HR, VTBI: 8.69 ML RANGE OFF EMPTY 56 MIN. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409377 PERFUSOR SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1