BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II ST 100-0, 5-S

    MDR report key: 3050613 · Received March 13, 2013

    Report

    Report Number
    3009089744-2013-00060
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 13, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED ONE USED, HALF FILLED (CONTAMINATED WITH CYTOSTATIC AGENT) EASYPUMP II ST 100-0, 5-2 WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. DAMAGES WERE NOT DETECTED. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED. THE WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED NO AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE AND WE DETECTED NO AIR INSIDE THE FLOW RESTRICTOR. WE DETECTED RESIDUES OF FLUID INSIDE THE LLA-CONE OF THE PT CONNECTOR. ADDITIONALLY THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE WHITE CLAMP AND WAITING FOR A WHILE, THE PUMP WORKED (SOLUTION WAS RUNNING). LEAKAGES WERE NOT DETECTED AT THE SAMPLE. FURTHERMORE WE TESTED THE FLOW RATE OF THE RECEIVED SAMPLE. (B)(4). WE HAVE INFORMED OUR PRODUCTION SITE ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): NO DRUG FLOW. DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106252 EASYPUMP II ST 100-0, 5-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2D2828ES11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other