BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 270-135-S

    MDR report key: 2945260 · Received February 1, 2013

    Report

    Report Number
    3009089744-2013-00010
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED TWO USED AND HALF FILLED EASYPUMP LL WITHOUT PACKAGING. SAMPLE 1: AT ONE SAMPLE THE WHITE CLAMP WAS CLOSED IN AS-RECEIVED CONDITION. MOREOVER, THE ORIGINAL WING CAP WAS NOT SUBMITTED BY THE CUSTOMER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). FURTHER ON WE DETECTED NO AIR INSIDE THE TRIANGLE TUBE (BEFORE AND BEHIND THE VENT FILTER); HOWEVER, WE DETECTED AIR BUBBLES INSIDE THE FLOW RESTRICTOR. FURTHERMORE, WE DETECTED RESIDUES OF CRYSTALLIZED DRUGS INSIDE THE LLA-CONE OF THE PT CONNECTOR. ADDITIONALLY, THE SAMPLE WAS TAKEN AS A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE WHITE CLAMP AND WAITING FOR A WHILE (1H), THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). LEAKS WERE NOT DETECTED. NO SPECIFIC CONCLUSION CAN BE DRAWN. SAMPLE 2: AT THE SECOND SAMPLE, THE WHITE CLAMP WAS MISSING IN AS-RECEIVED CONDITION. MOREOVER, THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER, THE LLA-CONE OF THE PT CONNECTOR WAS CLOSED WITH A RED COMBI STOPPER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). MOREOVER, WE DETECTED NO AIR INSIDE THE TRIANGLE TUBE (BEFORE AND BEHIND VENT FILTER); HOWEVER, WE DETECTED AIR BUBBLES INSIDE THE FLOW RESTRICTOR. IN ADDITION, WE DETECTED RESIDUES OF CRYSTALLIZED DRUGS INSIDE THE LLA-CONE OF THE PT CONNECTOR. AFTERWARDS THE SAMPLE WAS FILLED UP TO THE NOMINAL VALUE AND TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER REMOVING THE RED COMBI STOPPER AND WAITING FOR A WHILE, THE PUMP WORKED (SOLUTION WAS RUNNING). LEAKS WERE NOT DETECTED. FURTHERMORE, WE TESTED THE FLOW RATE OF THE RECEIVED SAMPLE. NOMINAL: 2 ML/H. ACTUAL: 1.9 ML IN 1 H; 3.9 ML IN 2 H; 5.8 ML IN 3 H. PROCEEDING ON THE ASSUMPTION THAT THE WHITE CLAMP WAS MISSING AT THE ORIGINAL PACKED SAMPLE ALREADY, WE ASSESS THIS COMPLAINT TO BE JUSTIFIED. WE HAVE INFORMED OUR PRODUCTION SITE ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT FROM THE PRODUCTION SITE 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)): THE PUMP CANNOT BE DRAINED COMPLETELY. THE PUMP SHOULD BE EMPTIED WITHIN 5 DAYS; HOWEVER, AFTER 7 DAYS IT WAS STILL COMPLETELY FILLED. DRUG: 5-FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44501 EASYPUMP II LT 270-135-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 1M1228EQ13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other