BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMP

    MDR report key: 5555287 · Received April 7, 2016

    Report

    Report Number
    9610825-2016-00195
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Date of Event
    February 6, 2016
    Report Date
    March 21, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MRZ
    PMA / PMN Number
    K083689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. (THE IMPORTER) IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT# (B)(4). THE ACTUAL PUMP INVOLVED IS NOT BEING RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE, LOGS AND OR ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. WITHOUT THE ACTUAL DEVICE OR LOGS, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. IF THE DEVICE, LOGS AND/ OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IN 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# (B)(4). THE ACTUAL SAMPLE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. MEDWATCH #MW5060216. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN A(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE, PRODUCT CODE AND/OR ADDTIONAL INFORMATION WERE NOT SUCCESSFUL. WITHOUT THE DEVICE OR PRODUCT CODE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND FURTHER EVALUATION IS NOT POSSIBLE.NO SPECIFIC CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. IF THE SAMPLE AND/OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION: FOLLOW UP #1 WAS SUBMITTED THROUGH THE GATEWAY ON AUGUST 29, 2016 BY A B.BRAUN EMPLOYEE THAT IS NO LONGER WITH BBRAUN MEDICAL INC. AS A RESULT, B. BRAUN WAS NOT ABLE TO RETRIEVE THE THREE REQUIRED ACKNOWLEDGEMENTS INDICATING SUCCESSFUL TRANMISSION AS THE ACCOUNT IS PASSWORD PROTECTED. A REQUEST WAS SUBMITTED TO THE ESG HELP DESK AND TICKET NUMBER 77390 WAS CREATED. MULTIPLE ATTEMPTS TO RESOLVE THIS ISSUE HAVE NOT BEEN SUCCESSFUL; THEREFORE FOLLOW UP #2 WILL SERVE AS THE REQUIRED SUBMISSION DOCUMENT PENDING SUCCESSFUL RETRIVAL OF THE THREE ACKNOWLEDGEMENTS - ATTACHMENT: [(B)(4).PDF]

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: MEDWATCH: MW5060216. EVENT DESCRIPTION: RENTAL B. BRAUN IV PUMP IN USE IN PATIENT ROOM "SPARKED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216059 ACCESSORIES FOR SPACE PUMP US. POWER CORD INCL. EXTENSION MRZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1