BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED INFUSION AMBULATORY INFUSION PUMP

    MDR report key: 5365460 · Received January 13, 2016

    Report

    Report Number
    1723533-2016-00001
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 12, 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 Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WALKMED INFUSION DOES NOT BELIEVE THAT THE EVENT WAS CAUSED OR CONTRIBUTED TO BY THE FAILURE OF ITS DEVICE(S). DUE TO THE LIMITED INFORMATION AVAILABLE, THIS HAS LIMITED WALKMED INFUSION'S INVESTIGATION OF THE EVENT. NO REPORTED DEVICE ISSUE; SERIAL UNKNOWN.

    Description of Event or Problem · 1

    DURING TREATMENT, A PATIENT CALLED WALKMED INFUSION'S 24-HOUR TECHNICAL SUPPORT LINE. THE PATIENT STATED SHE "IS IN CHEMO AND RADIO AND HER TEMPERATURE HAS BEEN OVER 100 DEGREES FOR THE LAST THREE DAYS. ALSO SHE HAS HAD DIARRHEA FOR SOME TIME AS WELL." THE CALLER (PATIENT) ALSO STATED SHE HAD BEEN GIVEN (B)(6) AND IT WILL GO TO 99 DEGREES. WALKMED INFUSION FOLLOWED UP WITH THE PATIENT TO CHECK STATUS AS WELL AS TO CLARIFY INFORMATION INITIALLY PROVIDED. THE PATIENT STATED SHE'S OKAY. SHE SAID SHE DID NOT HAVE ANY PROBLEMS WITH THE PUMP; SHE HAD SIDE EFFECTS OF THE MEDICINE SHE WAS ON. SHE SAID SHE KNEW THE SYMPTOMS SHE WAS EXPERIENCING WERE DUE TO HER MEDICATION AND NOT THE PUMP. SHE FOLLOWED UP WITH HER PHYSICIAN ON THE MONDAY AFTER EVENT AND IS DOING WELL. SHE WAS PRESCRIBED MEDICATION AND ANTIBIOTICS TO HELP HER WITH THE SYMPTOMS SHE WAS EXPERIENCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21707 WALKMED INFUSION AMBULATORY INFUSION PUMP INFUSION PUMP FRN WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other