BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 5540739 · Received April 1, 2016

    Report

    Report Number
    9610825-2016-00155
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    January 18, 2016
    Report Date
    March 16, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS 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 SAMPLE INVOLVED HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. EVENT 2: B. BRAUN MEDICAL INC. IS 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 NUMBER (B)(4). WE RECEIVED 2 USED EASYPUMP II LT 100-50-S-US WITHOUT PACKAGING. THE RECEIVED SAMPLES WERE TAKEN TO A VISUAL INSPECTION. AS-RECEIVED CONDITION: SAMPLE 1: THE SAMPLE WAS HALF FILLED. THE WHITE CLAMP IS CLOSED AND THE PATIENT CONNECTOR WAS NOT CLOSED (THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER). AFTER OPENING THE TOP CAP AND REMOVING OF THE CLOSING CONE WE DETECTED SOLUTION AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR (LLA-CONE). SAMPLE 2: THE SAMPLE WAS EMPTY. THE WHITE CLAMP IS CLOSED AND THE PATIENT CONNECTOR WAS NOT CLOSED (THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER). AFTER OPENING THE TOP CAP AND REMOVING OF THE CLOSING CONE WE DETECTED SOLUTION AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR (LLA-CONE). IN ADDITION THE SAMPLES WERE FILLED UP TO THE NOMINAL VALUE (100 ML) AND WERE TAKEN TO A FUNCTIONAL TEST RESPECTIVELY LEAK TEST. SAMPLE 1: AFTER STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP DID WORK (SOLUTION WAS RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. SAMPLE 2: AFTER STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE DETECTED. A LEAKAGE WAS DETECTED AT THE FILTER, THE SOLUTION RUNS OUT OF THE VENTILATION HOLE OF THE FILTER. ONE INSPECTED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. 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: EVENT 2. WHILE INFUSING THE DRUG FLUROURACIL CL (5 FU CL) THE CUSTOMER REPORTED THAT THE EASY PUMP DID NOT DELIVER THE TREATMENT TO THE PATIENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198476 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG 14K05GE551

    Patients

    Seq Age Sex Outcome Treatment
    1