BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP®

    MDR report key: 13599936 · Received February 25, 2022

    Report

    Report Number
    9610825-2022-00049
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Report Date
    June 8, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448843
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). EVENT 1: THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS RETURNED, INVESTIGATION COULD NOT BE COMPLETED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT 1: SAME FEMALE PATIENT HAD TWO INCIDENCES OF OVER INFUSION OF 5-FU, ENDED EARLY. INCIDENT ONE STARTED (B)(6) 2022 AT 3:40 PM FINISHED (B)(6) 2022 11:30 PM. EXPECTED TO BE 96-HOUR INFUSION. VOLUME IN PUMP 192 ML DOSE 4800 MG. PATIENT DEVELOPED MUCOSITIS - INTERVENTIONS REQUIRED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334642 EASYPUMP® PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 4540032-02 19H02GE631 04046964448843

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other