BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 100-50-S

    MDR report key: 3050578 · Received March 13, 2013

    Report

    Report Number
    3009089744-2013-00040
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 6, 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
    PO
    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 LT 100-50-S WITHOUT PACKAGING AND FOUR SAMPLES IN ORIGINAL PACKAGING. THE SAMPLES WERE TAKEN TO A VISUAL EXAMINATION. AT THE FOUR SAMPLES IN ORIGINAL PACKAGING DAMAGES WERE NOT DETECTED, BUT A FURTHER INVESTIGATION WAS NOT CARRIED OUT WITH THESE SAMPLES. AT THE USED SAMPLES, THE TUBES ARE INTENSIVELY TANGLED. AFTER UNTANGLING THE BIG KNOT IN THE INFUSION LINE WE DETECTED ANOTHER 4 KNOTS IN THE TUBES (2 KNOTS IN THE TRIANGLE TUBE AND 2 KNOTS IN THE MICROBORE TUBE). WITH REGARD TO THE RISK OF CONTAMINATION WITH THE CYTOSTATIC DRUG THESE KNOTS WERE NOT UNKNOTTED. THEREFORE, IT WAS NOT POSSIBLE TO CARRY OUT A FUNCTIONAL TEST RESPECTIVELY TO MEASURE THE FLOW RATE OF THIS COMPLAINT SAMPLE. FURTHER FINDINGS OF THE VISUAL EXAMINATION (USED SAMPLE): IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS MISSING. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. INSTEAD OF THIS A HYPODERMIC NEEDLE OF A COMPETITOR WAS ASSEMBLED ONTO THE PT CONNECTOR. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). FURTHER ON WE DID NOT DETECT AIR INSIDE THE TRIANGLE TUBE BUT AN AIR BUBBLE INSIDE THE FLOW RESTRICTOR. FURTHERMORE, WE DETECTED RESIDUES OF FLUID INSIDE THE LLA-CONE OF THE PT CONNECTOR. IN ADDITION, THE FILLING PORT (LLI-CONE) WAS TAKEN TO A LEAK TEST. A LEAKAGE WAS NOT DETECTED. 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 INFO BY (B)(4) SALES ORGANIZATION IN (B)(4)): AFTER 48 HOURS, THE INFUSION PUMP CONTAINED ABOUT HALF OF THE INITIAL VOLUME. THIS INCIDENT OCCURRED IN +/- 7 DIFFERENT INFUSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106801 EASYPUMP II LT 100-50-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2C1428EH11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other