BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 270-27-S

    MDR report key: 2945187 · Received January 31, 2013

    Report

    Report Number
    3009089744-2013-00005
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 31, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). WE RECEIVED ONE USED QUARTER-FILLED (CONTAMINATED WITH CYTOSTATIC AGENT), EASYPUMP II LT (B)(4) WITHOUT PASSAGE. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. DAMAGES WERE NOT DETECTED AT THE SAMPLE. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED AND THE LOSING CONE AT THE TOP CAP WAS MISSING. AFTER OPENING THE TOP CAP, WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). MOREOVER WE DETECTED NO AIR INSIDE THE TUBE HOWEVER ONE AIR BUBBLE WAS DETECTED INSIDE THE FLOW RESTRICTOR. IN ADDITION WE DETECTED RESIDUES OF FLUID INSIDE THE LLA-CONE OF THE PT CONNECTOR. AFTERWARDS THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY TO A LEAK TEST. AFTER OPENING THE WHITE CLAMP AND WAITING FOR A WHILE, THE PUMP WORKED (SOLUTION WAS RUNNING). LEAKAGES WERE NOT DETECTED. FURTHERMORE THE FLOW RATE WAS TESTED. NOMINAL: 10 ML/H. ACTUAL: 9.8 ML IN 1 H; 19.4 ML IN 2 H; 29.2 ML IN 3 H. THE RECEIVED SAMPLE IS WITHIN OUR REQUIREMENTS. NEVERTHELESS WE HAVE INFORMED OUR PRODUCTION SITE ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT OF THE PRODUCTION SITE IS AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(6)): STOP OF THE INFUSION. DRUG: TAZOCILLINE 8G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43023 EASYPUMP II LT 270-27-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 1M0128ED12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other