BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPUMP

    MDR report key: 16582439 · Received March 21, 2023

    Report

    Report Number
    9610825-2023-00089
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 21, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    PMA / PMN Number
    K081905
    Adverse Event
    Yes
    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 SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS A VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. 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: DETAILED INQUIRY DESCRIPTION: 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. THE PATIENT EXPERIENCED CARDIAC SYMPTOMS: CHEST PAIN. HE WENT TO EMERGENCY ROOM (ER) AND EKC APPEARED TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358095 EASYPUMP PUMP, INFUSION, ELASTOMERI MEB B. BRAUN MELSUNGEN AG 4540018-02 22F17GE561 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization