BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY PUMP

    MDR report key: 16437474 · Received February 23, 2023

    Report

    Report Number
    MW5115165
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 20, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BBRAUN EASYPUMP 250/250, LOT: 22D5GE712, EXP: 04/01/2027 LEAKED IN THE CLEAN ROOM WHILE COMPOUNDING FOR A PATIENT. THE PRODUCT LEAKED WHERE THE TUBING OF THE EASYPUMP CONNECTS TO THE "BALL" OF THE PRODUCT; 5 BALLS LEAKED AND REQUIRED US HAVING TO REMIX. THESE BALLS NEVER MADE IT TO THE PATIENT. THE INCIDENT WAS REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856582 EASY PUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MEDICAL INC. 250/250 22D25GE712

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose BED BALL X 5| MEROPENEM| SODIUM CHLORIDE | STERILE WATER