BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALKMED 350VL INFUSION PUMP

    MDR report key: 4907555 · Received July 10, 2015

    Report

    Report Number
    1723533-2015-00013
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 14, 2015
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WALKMED INFUSION PROVIDES A PHONE NUMBER SO PATIENTS 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 A CALLER INQUIRING ABOUT THE DISPOSITION OF THE PUMP AFTER HIS SPOUSE HAD PASSED AWAY. WHEN WALKMED INFUSION RECEIVED THIS INFORMATION, A PHONE CALL WAS PLACED FOR THE CLINIC'S OFFICE TO INQUIRE ABOUT THE PATIENT. PER THE PHONE CONVERSATION WITH THE CLINIC'S OFFICE, THE CALLER'S INTENT IN CALLING WALKMED INFUSION'S 24 HOUR CUSTOMER SUPPORT LINE WAS TO SIMPLY DETERMINE WHAT TO DO WITH THE DEVICE AND WHERE TO PUT IT. THERE IS NO ALLEGATION THAT WALKMED INFUSION'S PRODUCT CAUSED THE PATIENT TO EXPIRE. THE CLINIC DOES NOT BELIEVE THAT THE DEVICE LED TO THE DEATH OF A PATIENT HOWEVER, WALKMED IS SEEKING TO HAVE THE DEVICE RETURNED TO CONDUCT AN EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 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
    451169 WALKMED 350VL INFUSION PUMP AMBULATORY INFUSION PUMP FRN WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death