BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYPUMP II

    MDR report key: 4353270 · Received December 17, 2014

    Report

    Report Number
    9610825-2014-00461
    Event Type
    Death
    Date Received
    December 17, 2014
    Date of Event
    September 29, 2014
    Report Date
    November 21, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM IN (B)(4) FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. REVIEWED THE DEVICE HISTORY RECORD TO BMPTH IN SAP SYSTEM AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS INSPECTION AND FINAL CONTROL INSPECTION. ISSUE WAS CAUSED BY AN APPLICATION ERROR OF THE PHARMACIST. PATIENT RECEIVED A 200 ML/H INSTEAD OF THE REQUESTED 2 ML/H DEVICE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(4)): THE PT SOLD HIS EASYPUMP TO RETAIL PHARMACY AND THE HOSPITAL HAS DISPENSED BY ERROR AN EASYPUMP 200 ML/H INSTEAD OF 2 ML/H. DRUG INFUSED: ANTINEOPLASTIC DRUG. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826535 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG NA 2F2328EA21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death