BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5573020 · Received April 13, 2016

    Report

    Report Number
    9610825-2016-00205
    Event Type
    Malfunction
    Date Received
    April 13, 2016
    Report Date
    March 15, 2016
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    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). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED YET AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INSPECTION RESULTS BECOME AVAILABLE.

    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). WE RECEIVED ONE USED AND FILLED EASYPUMP II ST 250-1-S-US IN WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. THE WHITE CLAMP WAS CLOSED AND THE PATIENT CONNECTOR WAS NOT CLOSED, THE ORIGINAL WING CAP WAS NOT HANDED OVER FROM THE CUSTOMER. DAMAGES THAT WOULD LEAD TO A MALFUNCTION WERE NOT DETECTED AT THE SAMPLE. AFTER OPENING THE TOP CAP WE DETECTED CRYSTALLIZED DRUG RESIDUES AND SOLUTION AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. IN ADDITION THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE WHITE CLAMP AND STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP IS NOT WORKING (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE INSPECTED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. DEVICE HISTORY RECORDS (DHR): REVIEWED DEVICE HISTORY RECORDS, NO ABNORMALITIES AND NO SUCH DEFECT NOTED AT FINAL CONTROL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: PRODUCT: 4540048-02. LOT 14N24GE711. PROBLEM: PUMP IS NOT PUMPING. WHEN YOU OPEN THE CLAMP NOTHING IS HAPPENING. THE PATIENT NOTICED THIS AND RETURNED IT TO THE PHARMACY. NO DELAY IN CARE DUE TO PATIENT HAVING ANOTHER PUMP THAT WAS FUNCTIONING FINE. IT WAS FILLED WITH MOSTLY NORMAL SALINE AND SOME VANCOMYCIN. PATIENT IS MALE IN MID 50S. NO PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230091 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B.BRAUN MELSUNGEN AG N/A 14N24GE711

    Patients

    Seq Age Sex Outcome Treatment
    1