BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 2850294 · Received November 2, 2012

    Report

    Report Number
    9610825-2012-00209
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    February 15, 2012
    Report Date
    November 2, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, DATING BACK ONE YEAR REVEALED NO ADVERSE TRENDS OF THIS NATURE AGAINST P/N 8713112C. ONE POWER CORD, PART NUMBER 8713050U, WERE RECEIVED FOR EVALUATION. THE POWER CORD EXHIBITED A CHARRED APPEARANCE BETWEEN THE EXTENSION CORD AND THE POWER SUPPLY. THE INFORMATION REGARDING THIS EVENT WAS FORWARDED TO THE MANUFACTURER, B. BRAUN (B)(4) FOR EVALUATION. PER B. BRAUN (B)(4)'S EVALUATION, IT WAS CONCLUDED THAT WAS POSSIBLE THAT MOISTURE COULD HAVE COME INTO CONTACT WITH THE PART AND CAUSED A SHORT CIRCUIT BETWEEN THE POWER CORD EXTENSION AND THE POWER SUPPLY. HOWEVER, THIS POTENTIAL ROOT CAUSE COULD NOT BE DEFINITIVELY CONFIRMED. IT IS IMPORTANT TO NOTE THAT WITHIN THE IFU FOR THE INFUSOMAT SPACE PUMP, IT DOES INDICATE TO "PROTECT THE DEVICE AND THE POWER SUPPLY AGAINST MOISTURE."

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER SAID HE WAS SENDING SOMETHING IN FOR B. BRAUN TO TAKE A LOOK AT IT AND THE OCCURRENCE HAD BEEN DESCRIBED AS "SPARKING" AND "SMOKING" OF AN ELECTRICAL ACCESSORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESSORIES FOR SPACE PUMPS US POWER CORD INCL. EXTENSION FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other