BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 5484610 · Received March 7, 2016

    Report

    Report Number
    9610825-2016-00097
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Report Date
    February 8, 2016
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE 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). MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THE ACTUAL DVICE AND /OR THE DEVICE LOGS WERE NOT SUCCESSFUL. WITHOUT THE DEVICE OR LOGS, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN. IF THE DEVICE, LOGS OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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 MELSUNGEN AG INTERNAL REPORT (B)(4). RESULT OF EXAMINATION: THE HISTORY LOG FILES OF THE RECEIVED SAMPLE WERE READ AND ANALYZED. NO HINTS FOR A DEVIATION OF THE DELIVERY ACCURACY WERE FOUND. THEREUPON THE INFUSOMAT SPACE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. THE DEVICE SHOWED AGE-BASED MARKS OF USE AND WAS HEAVILY CONTAMINATED. IT WAS ASSESSED THAT THIS SAMPLE HAD ALREADY BEEN OPENED PRIOR TO THIS EXAMINATION, BECAUSE THE COVER CAPS AND THE SEALING WERE MISSING. THE SPACELINE, WHICH WAS ENGAGED FOR TECHNICAL PURPOSES, WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. A START-UP WAS POSSIBLE WITHOUT RESERVATIONS. THE DOOR BOLT DRIVE GENERATED A STRANGE NOISE WHILE MOVING. FOR CHECKING THE DELIVERY ACCURACY THE DELIVERY RATE OF THE DEVICE WAS TESTED ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK THREE TIMES. ALL MEASURED VALUES WERE SLIGHTLY OUT OF ITS SPECIFICATION. HOWEVER, THE PRESSURE STAGES WERE WITHIN SPECIFICATION. FURTHERMORE THE INSIDE OF THE DEVICE WAS INVESTIGATED. INSIDE WE DETECTED SEVERAL INDICATIONS FOR A DROP DAMAGE. THE PUMP OPERATED NOT AS INTENDED AND THE REPORTED FAILURE WAS COMPREHENSIBLE. HOWEVER, WE FOUND SEVERAL INDICATIONS FOR A MISHANDLING OF THE INSTRUCTIONS FOR USE. FOLLOWING IS DESCRIBED IN THE INSTRUCTIONS FOR USE: PRIOR TO ADMINISTRATION, VISIBLY INSPECT THE PUMP FOR DAMAGE, MISSING PARTS OR CONTAMINATION AND CHECK AUDIBLE AND VISIBLE ALARMS DURING SELF TEST. PROTECT THE DEVICE AND THE POWER SUPPLY AGAINST MOISTURE. IF THE PUMP FALLS DOWN OR IS EXPOSED TO FORCE, IT MUST BE CHECKED BY THE SERVICE DEPARTMENT.

    Description of Event or Problem · 0

    OCCURRED IN THE NICU, WEEK OF (B)(6) 2016 (NO SPECIFIC DATE). PATIENT WAS RECEIVING MULTIPLE INFUSIONS; PARENTERAL NUTRITION THROUGH BAXTER SPECTRUM PUMP, SMOF LIPIDS THROUGH BBRAUN SYRINGE PUMP, MORPHINE THROUGH BBRAUN SYRINGE PUMP. ALL TUBING CONNECTED TO PATIENT ON A 3-WAY CATHETER EXTENSION SET. CLINICIAN NOTICED THE LIPID FROM ONE SYRINGE PUMP BACKING UP INTO THE OTHER SYRINGE PUMP TUBING. INFUSIONS WERE STOPPED. PICCLINE BECAME OCCLUDED, PICC WAS REMOVED AND NEW PICCLINE WAS STARTED TO CONTINUE WITH PRESCRIBED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139185 PERFUSOR SPACE INFUSION PUMP FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1