BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5520495 · Received March 23, 2016

    Report

    Report Number
    9610825-2016-00141
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 1, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 MELSUNGEN AG INTERNAL REPORT # (B)(4). STATEMENT FROM MANUFACTURER: DEFINE: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 270-27-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP WAS STILL ATTACHED TO THE PUMP. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED. NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS LEFT FOR AWHILE. THE PUMP REMAINED NOT WORKING. NO OTHER DEVIATION WAS OBSERVED. ANALYSIS: COMPLAINT SAMPLE WAS CHECKED FOR KINKED TUBE. FOUND TRIANGLE TUBE OF COMPLAINT SAMPLE WAS KINKED INSIDE BIG BOTTOM CAP (BBC). AFTER THE KINKED TUBE WAS RELEASED, COMPLAINT SAMPLE WAS FLOWING. CONCLUSION: COMPLAINT SAMPLE WAS BLOCKED DUE TO KINKED TRIANGLE TUBE INSIDE BBC. BLOCKAGE DUE TO KINKED TUBE WAS ADDRESSED IN CAPA001475. JUSTIFICATION: JUSTIFIED.

    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). WE RECEIVED ONE USED AND FILLED EASYPUMP II LT 270-27-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. THE WHITE CLAMP WAS NOT CLOSED AND THE PATIENT CONNECTOR WAS CLOSED WITH THE ORIGINAL WING CAP. DAMAGES THAT WOULD LEAD TO A MALFUNCTION WERE NOT DETECTED ON THE SAMPLE. AFTER OPENING THE TOP CAP WE DETECTED SOLUTION AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY LEAK TEST. AFTER STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE INSPECTED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): THE PUMP DIDN'T WORK. AFTER THE FILLING THERE IS NO VISIBLE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176067 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 14N02GE222

    Patients

    Seq Age Sex Outcome Treatment
    1