BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED PCA AMBULATORY PUMP

    MDR report key: 4210862 · Received August 29, 2014

    Report

    Report Number
    1723533-2014-00008
    Event Type
    Injury
    Date Received
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    WALKMED INFUSION LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, MR (B)(6) NA REPORTED, "BOLUS INFUSION REGARDLESS OF INFUSION RATE." ON (B)(4), 2014, ADDITIONAL INFO WAS REQUESTED. WALKMED INFUSION HAD REQUESTED MR NA COMPLETE A CUSTOMER FEEDBACK FORM. A REPLY NOR A COMPLETED CUSTOMER FEEDBACK FORM WERE RETURNED. ON (B)(6) 2014, DETAILS SURROUNDING THE EVENT WERE REQUESTED FROM MR NA. A REPLY WAS NOT RECEIVED. ON (B)(6) 2014, A FOLLOW-UP MESSAGE WAS SENT TO MR NA IN REGARDS TO OBTAINING ADDITIONAL EVENT DETAILS. ON (B)(6) 2014, MR NA REPORTED "BOLUS INFUSION REGARDLESS OF THE SETTING VALUE." IN REGARDS TO PT INJURY, MR NA REPORTED, "TRANSFER TO THE ICU AFTER COMA." ADDITIONALLY, THE FOLLOWING PARAMETERS WERE PROVIDED: "SETTING VALUE: BASAL RATE: 1.0ML/HR, BOLUS: 1.0ML/BOLUS, LOCK OUT (B)(6) 2014, THE FOLLOWING QUESTIONS WERE ASKED: A REPLY HAS NOT BEEN RECEIVED FOR THE 13 QUESTIONS THAT WERE DIRECTED TO MR NA. IT IS UNCLEAR WHETHER THE PUMP WAS DIRECTLY INVOLVED IN THE PT'S COMA. ADDITIONALLY, WALKMED INFUSION DOES NOT EXPECT THE PUMP'S RETURN FOR AN INVESTIGATION.

    Description of Event or Problem · 1

    THE PUMP DELIVERED MORE MEDICATION TO THE PT THAN THE FACILITY HAD INTENDED. THE PT WAS SENT TO THE ICU AFTER THEY HAD FALLEN INTO A COMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530022 WALKMED PCA AMBULATORY PUMP AMBULATORY INFUSION PUMP FRN WALKMED INFUSION LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization