BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5501172 · Received March 15, 2016

    Report

    Report Number
    9610825-2016-00111
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 18, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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). 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 NOT OBSERVED AT THE PUMP. THE PATIENT CONNECTOR WAS ATTACHED TO A VIAL. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. VIAL WAS REMOVED AND CLAMP CLIP WAS RELEASED. IMMEDIATELY OBSERVED FLOW OF SOLUTION. THE COMPLAINT SAMPLE WAS WORKING. NO OTHER DEVIATION WAS OBSERVED. CONCLUSION: BLOCKAGE DEFECT AS MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THEREFORE, THE COMPLAINT IS CLASSIFIED AS NOT "JUDGABLE".

    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). CUSTOMER COMPLAINED THAT THE PUMP WHICH WAS CONNECTED TO THE PATIENT, AFTER 24 HOURS WHEN THE NURSE WANTED TO CHANGE THE ANTIBIOTICS, THE PUMP WAS BLOCKED AND DID NOT PROVIDE THE MEDICATION TO THE PATIENT. THE CAUSE FOR BLOCKAGE COULD NOT BE DEFINE BY THE COMPLAINT INVESTIGATOR, HENCE SAMPLE WAS FORWARDED TO PRODUCTION FOR FURTHER EVALUATION AND INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. RECEIVED ONE USED OF EASYPUMP II LT 125-25-S WITHOUT PACKAGING AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME 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)): EASYPUMP II NOT WORKING CORRECTLY. CONNECTED TO PATIENT. NURSE CAME TO CHANGE OVER 24 HOURS LATER AND ANTIBIOTICS HAD NOT INFUSED. PUMP HAS NOT PROVIDED THE MEDICATION TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157480 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 14L15GE22R

    Patients

    Seq Age Sex Outcome Treatment
    1