BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALKMED WM350VL INFUSION PUMP

    MDR report key: 4808661 · Received June 1, 2015

    Report

    Report Number
    1723533-2015-00008
    Event Type
    Death
    Date Received
    June 1, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 29, 2015
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WALKMED INFUSION PROVIDES A PHONE NUMBER SO PATIENT'S CAN CALL TO ASK QUESTIONS PERTAINING TO THEIR WALKMED INFUSION PUMP. THIS PHONE LINE IS OPEN 24 HOURS A DAY, 7 DAYS A WEEK. HOWEVER, THE OPERATOR OF THIS PHONE LINE RECEIVED A PHONE CALL FROM AN EMERGENCY ROOM NURSE TO INQUIRE ABOUT THE DISPOSITION OF THE WALKMED INFUSION PRODUCTS AFTER THE PATIENT HAD EXPIRED. WHEN WALKMED INFUSION RECEIVED THIS INFORMATION, A PHONE CALL WAS PLACED FOR THE PHYSICIAN'S OFFICE TO INQUIRE ABOUT THE PATIENT.PER THE PHONE CONVERSATION WITH THE PHYSICIAN'S OFFICE, THE PATIENT WAS NOT DOING VERY WELL IN HIS HEALTH PRIOR TO USING THE WALKMED INFUSION PUMP. THE PUMP WAS SET UP AND HE LEFT THEIR OFFICE ABOUT 12 HOURS PRIOR TO PASSING AWAY. THE OFFICE WAS NOTIFIED IMMEDIATELY OF HIS DEATH AND HIS PUMP AND BAG WERE CHECKED FOR ANY MALFUNCTIONS OR ISSUES. THE PUMP DID NOT HAVE ANY MALFUNCTION, ERRORS, OR ISSUES AND THE PROPER AMOUNT OF MEDICATION HAD DISPENSED WITHIN THE TIME FRAME. THE BAG HAD APPROXIMATELY 100CC OF 5FU AND ONLY 25CC HAD INFUSED AT A RATE OF 2.17CC/HR. THE INTENT IN CALLING WALKMED INFUSION'S 24 HOUR CUSTOMER SUPPORT LINE WAS TO SIMPLY LEARN HOW TO POWER OFF THE DEVICE AND WHERE TO PUT IT. THERE IS NO ALLEGATION THAT WALKMED INFUSION'S PRODUCT CAUSED THE PATIENT TO EXPIRE. THE CLINICAL STAFF DID NOT RECORD THE PUMP'S SERIAL NUMBER AS THE CAUSE OF DEATH IS RELATED TO NATURAL CAUSES STEMMING FROM THE PATIENT'S DECLINING STATE OF HEALTH.

    Description of Event or Problem · 1

    ON (B)(4) 2015, WALKMED INFUSION WAS NOTIFIED OF A PATIENT'S DEATH WHILE THE PATIENT WAS CONNECTED TO A WALKMED WM350VL INFUSION PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353433 WALKMED WM350VL INFUSION PUMP AMBULATORY INFUSION PUMP FRN WALKMED INFUSION, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death