BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 16982574 · Received May 23, 2023

    Report

    Report Number
    9610825-2023-00229
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 30, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLES OR PHOTOS WERE SUBMITTED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. IF THE DEVICE DOES BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR FURTHER EVALUATION. THE COMPLAINT IS CONSIDERED NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: A PATIENT'S 48HR EASYPUMP INFUSED OVER 30 HOURS FOR 2 CYCLES WITH POSSIBLE CARDIOTOXICITY. THE PATIENT HAD A C2D1 FOLFOX. THE PATIENT WAS DISCHARGED HOME WITH A HOME INFUSION PUMP FILLED WITH 5 FU MEDICATION AND IT WAS SUPPOSED TO BE INFUSED OVER 48 HOURS. PER PATIENT, THE PUMP FINISHED AFTER 30 HOURS AND THE PATIENT EXPERIENCED CARDIAC SYMPTOMS: CHEST PAIN. HE WENT TO ER AND EKC APPEARED TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256838 EASYPUMP PUMP, INFUSION, ELASTOMERI MEB B. BRAUN MELSUNGEN AG 4540018-02 22F17GE561 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown