BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5486677 · Received March 8, 2016

    Report

    Report Number
    9610825-2016-00079
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Report Date
    February 11, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    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 · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). WE RECEIVED ONE USED, PROBABLY COMPLETELY FILLED EASYPUMP II LT 270-135-S WITHOUT PACKAGING (ACCORDING TO THE CUSTOMER CONTAMINATED WITH A CYTOSTATIC DRUG). THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED BUT DID NOT BLOCK THE TRIANGLE TUBE (MISTAKE WHILE CLOSING THE CLAMP). THE ORIGINAL WING CAP WAS NOT ON THE PATIENT CONNECTOR; THE PATIENT CONNECTOR WAS NOT BLOCKED. AFTER OPENING THE TOP CAP WE DETECTED RESIDUES OF SOLUTION (LIQUID) AT THE FILLING PORT (LLI-CONE). IN ADDITION, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE PATIENT CONNECTOR. THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. THE PUMP WAS STORED FLAT (TUBE WAS NOT BLOCKED BY THE CLAMP RESPECTIVELY PATIENT CONNECTOR WAS NOT CLOSED) AND WE WAITED 60 MINUTES BUT THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE INSPECTED SAMPLE IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # STATEMENT FROM MANUFACTURER: CRYSTALLIZATION DUE TO RESIDUES IS A KNOWN ISSUE AND CAPA 1475 HAS BEEN INITIATED TO ADDRESS THIS MATTER. HENCE WE ASSESS THIS COMPLAINT TO BE JUSTIFIED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): OUR (B)(4) COLLEAGUE SEND US A BIOHAZARD BOX WITH AN EASYPUMP FULL OF 5-FU FOR A PERIOD OF 7 DAYS WHICH WAS NOT ADMINISTERED TO A PATIENT AT DAY HOSPITAL OF THIS HOSPITAL. THIS SITUATION HAS ALREADY BEEN REPEATED ON 3 PATIENTS ACCORDING TO THE INFORMATION PROVIDED BY THE HEAD NURSE, AND THE CUSTOMER WILL LOOK FOR AN ALTERNATIVE FOR THE CYCLES OF 7 DAYS THAT SOME PATIENTS DO AT THE HOSPITAL. THE SAME EASYPUMP WHEN USED FOR THE CYCLES OF 5 DAYS DON'T GIVE ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141633 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15B17GE341

    Patients

    Seq Age Sex Outcome Treatment
    1