BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 100-200-S

    MDR report key: 3063518 · Received April 12, 2013

    Report

    Report Number
    3009089744-2013-00085
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 12, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED 13 USED EASYPUMP II LT 100-200-S WITHOUT PACKAGE. THE RECEIVED SAMPLES WERE SUBJECTED TO A VISUAL EXAMINATION. AT ONE SAMPLE, THE CONNECTION BETWEEN TUBE/ VENT FILTER WAS DETACHED. DAMAGES AT THE OTHER 12 SAMPLES WERE NOT DETECTED. THE SAMPLES WERE ASSIGNED BY THE CUSTOMER WITH VARIOUS QUANTITIES OF SOLUTION INSIDE THE PUMPS. AS-RECEIVED CONDITION OF THE 13 SAMPLES: SAMPLE 1: THE USED PUMP WAS EMPTY. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. WE DETECTED SOLUTION (LIQUID) INSTEAD OF CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEHIND THE VENT FILTER) AND INSIDE THE FLOW RESTRICTOR. FURTHERMORE WE DETECTED NO FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 2: THE USED PUMP WAS COMPLETELY FILLED WITH SOLUTION. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. WE DETECTED SOLUTION (LIQUID) INSTEAD OF CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEHIND THE VENT FILTER) AND INSIDE THE FLOW RESTRICTOR. FURTHERMORE WE DETECTED NO FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 3: THE USED PUMP WAS EMPTY. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS OPEN. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE AND THE FLOW RESTRICTOR WERE NOT DETECTED. FURTHERMORE WE DETECTED FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 4: THE USED PUMP WAS EMPTY. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. WE DETECTED SOLUTION (LIQUID) INSTEAD OF CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEHIND THE VENT FILTER) AND INSIDE THE FLOW RESTRICTOR. FURTHERMORE WE DETECTED NO FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 5: THE USED PUMP WAS EMPTY. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED NO AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE BUT AN AIR BUBBLE INSIDE THE FLOW RESTRICTOR WAS VISIBLE. FURTHERMORE WE DETECTED NO FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 6: THE USED PUMP WAS COMPLETELY FILLED WITH SOLUTION. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER, THE PUMP WAS CLOSED WITH A CANNULA. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEHIND THE VENT FILTER) AND INSIDE THE FLOW RESTRICTOR. FURTHERMORE WE DETECTED FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 7: THE USED PUMP WAS THREE QUARTER FILLED WITH SOLUTION. THE COMPLETE PUMP AND TUBE WERE GREYLY DISCOLORED. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER, THE PUMP WAS CLOSED WITH A CANNULA. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEFORE THE VENT FILTER) AND INSIDE THE FLOW RESTRICTOR. FURTHERMORE WERE DETECTED FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 8: THE USED PUMP WAS COMPLETELY FILLED WITH SOLUTION. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS STILL AT THE PATIENT CONNECTOR. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING TO TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEHIND THE VENT FILTER) AND INSIDE THE FLOW RESTRICTOR. FURTHERMORE WE DETECTED NO FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 9: THE USED PUMP WAS THREE QUARTER FILLED WITH SOLUTION. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEHIND THE VENT FILTER). AIR INSIDE THE FLOW RESTRICTOR WERE NOT DETECTED. FURTHERMORE WE DETECTED FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 10: THE USED PUMP WAS HALF FILLED WITH SOLUTION. THE COMPLETE PUMP AND TUBE ARE BLACK DISCOLORED. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER, THE PUMP WAS CLOSED WITH A CANNULA. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED NO AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE BUT AN AIR BUBBLE INSIDE THE FLOW RESTRICTOR WAS VISIBLE. FURTHERMORE WE DETECTED FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 11: THE USED PUMP WAS QUARTER FILLED WITH SOLUTION. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS STILL AT THE PATIENT CONNECTOR. CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE WERE DETECTED. AFTER OPENING THE TIP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEING THE VENT FILTER). AIR INSIDE THE FLOW RESTRICTOR WERE NOT DETECTED. FURTHERMORE WE DETECTED NO FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 12: THE USED PUMP WAS QUARTER FILLED WITH SOLUTION. DAMAGES WERE NOT DETECTED AND THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. CRYSTALLIZED DRUG RESIDUES OUT SIDE OF THE SAMPLE WERE NOT DETECTED. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). WE DETECTED AIR INSIDE THE TRIANGLE TUBE OR MICROBORE TUBE (BEHIND THE VENT FILTER). AIR INSIDE THE FLOW RESTRICTOR WERE NOT DETECTED. FURTHERMORE WE DETECTED NO FLUID INSIDE THE LLA-CONE OF THE PATIENT CONNECTOR. SAMPLE 13: THE CONNECTION BETWEEN TUBE / VENT FILTER WAS DETACHED. IN ADDITION THE SAMPLES WERE FILLED WITH NACL 0.9% UP TO THE NOMINAL VOLUME AND TAKEN TO A FUNCTIONAL TEST, RESPECTIVELY LEAK TEST, IN A PERIOD OF ONE HOUR. AFTER OPENING THE WHITE CLAMP AND WAITING FOR A WHILE, 10 PUMPS DID WORK (SOLUTION WAS RUNNING). AT 5 OF THAWS 10 SAMPLES IMMEDIATELY LEAKS WERE DETECTED (SAMPLE 1, 3, 4, 9 AND 11 WERE LEAKAGE). AT THE 5 LEAKAGE SAMPLES IT WAS NOT POSSIBLE TO CARRY OUT A FUNCTIONAL TEST RESPECTIVELY TO MEASURE THE FLOW RATE. AT SAMPLES 10 AND 12 THE SOLUTION WAS NOT RUNNING. DESPITE SQUEEZING BOTH PUMPS BY HAND, THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). WITH THE REST SAMPLES WE TESTED THE FLOW RATE. NOMINAL: 0.5 ML/H ACTUAL: 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)): PUMP DID NOT FLOW/ STARTED TO FLOW ONLY AFTER SEVERAL DAYS. DRUG PERFUSED AND CONCENTRATION: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159101 EASYPUMP II LT 100-200-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2D2828ES11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other