BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED INFUSION 350VL AMBULATORY INFUSION PUMP

    MDR report key: 5365461 · Received January 13, 2016

    Report

    Report Number
    1723533-2016-00002
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 8, 2015
    Report Date
    December 14, 2015
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO WALKMED INFUSION FOR PRODUCT EVALUATION. THE DEVICE IN QUESTION UNDERWENT PRODUCT EVALUATION TESTING AT WALKMED INFUSION AND PASSED ALL THE ELECTRICAL TESTING AND RELEVANT PRODUCT EVALUATION TESTS. THE REPORTED ERROR COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    FURTHER FOLLOW UP WITH THE INITIAL REPORTER CONFIRMED THAT THE PATIENT DID HAVE THE PHONE NUMBER FOR THE PHYSICIAN'S OFFICE, BUT EITHER GOT FLUSTERED OR FORGOT TO CALL THEM AT THE TIME OF THE EVENT. THE PATIENT INSTEAD CALLED WALKMED INFUSION'S 24-HOUR TECHNICAL SUPPORT LINE AT THE TIME OF THE EVENT. WALKMED INFUSION HAS RECEIVED THE DEVICE IN QUESTION FOR A PRODUCT EVALUATION. THE DEVICE EVALUATION AND FAILURE INVESTIGATION ARE PENDING AND NOT YET COMPLETED.

    Description of Event or Problem · 1

    DURING TREATMENT, A PATIENT CALLED WALKMED INFUSION'S 24-HOUR TECHNICAL SUPPORT LINE. THE PATIENT STATED SHE WAS GETTING AN ERROR ALARM ON THE DEVICE IN QUESTION. THROUGH THE TECHNICAL SUPPORT LINE SHE WAS ABLE TO TROUBLESHOOT THE ERROR ALARM AND CONTINUE HER INFUSION. THE SAME ERROR MESSAGE AND ALARM OCCURRED AGAIN AND SHE WAS ADVISED TO CALL THE HOSPITAL. THE HOSPITAL WAS UNABLE TO HELP HER AND SHE WAS THEN ADVISED BY THE HOSPITAL TO CALL THE FIRE DEPARTMENT. THE FIRE DEPARTMENT RESPONDED AND CALLED THE 24-HOUR TECHNICAL SUPPORT LINE TO TROUBLESHOOT THE ERROR MESSAGE ALARM. THE PATIENT REPORTED THAT THIS ERROR OCCURRED FREQUENTLY AND HAD TO RESTART THE DEVICE UNTIL SHE WAS ABLE TO SEE HER PHYSICIAN'S OFFICE TWO DAYS LATER. THE PATIENT EXPERIENCED EMOTIONAL DISTRESS DURING HER TREATMENT AND TROUBLESHOOTING THE ERROR ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22397 WALKMED INFUSION 350VL AMBULATORY INFUSION PUMP INFUSION PUMP FRN WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other