BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 10755154 · Received October 29, 2020

    Report

    Report Number
    9610825-2020-00275
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 25, 2020
    Report Date
    October 29, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 16K04GE201, THERE IS NO SUCH DEFECT DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION PERTAINING TO FAST FLOW RATE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): PUMP INFUSED TOO QUICKLY. PUMP USED FOR EPI MEDICATION. PUMP INFUSED TOO QUICKLY, SUPPOSED TO EMPTY WITHIN 8 HOURS, BUT IT WAS EMPTY AFTER 5 HOURS. THE PUMP PLACED CORRECTLY ADHERED TO THE SKIN, AND PLACED IN THE SAME HIGHT AS THE INSERTION SITE. NO LEAKAGE OF LIQUID. THE PUMP WAS UNFORTUNATELY NOT KEPT, AS THERE WAS NO ATTENTION OF THIS DURING SHIFT BETWEEN MIDWIFES AT THE WARD. NO FURTHER CONSEQUENCES (HARM) FOR THE PATIENT, ONLY INCORRECT DOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223003 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 16K04GE201

    Patients

    Seq Age Sex Outcome Treatment
    1