BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    MDR report key: 1023307 · Received April 1, 2008

    Report

    Report Number
    6000001-2008-00199
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    MEB
    PMA / PMN Number
    K905778
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE NATIONAL COMPLAINT COORDINATOR (NCC) FOR BAXTER RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING AN OVER INFUSION OF THE BASAL/BOLUS INFUSOR DURING PT USE. THE DEVICE WAS FILLED WITH MEDICATION (ROPIVACAINE HYDROCHLORIDE HYDRATE 96ML) AND CONNECTED TO A PT VIA EPIDURAL CATHETER. THE FACILITY REPORTED A DROP IN BLOOD PRESSURE WAS OBSERVED FROM A SYSTOLIC OF 120 TO 80. AN ANTIHYPERTENSIVE (UNK) MEDICATION WAS ALSO BEING ADMINISTERED PRIOR TO SURGERY DUE TO THE HIGH BLOOD PRESSURE, BUT WAS STOPPED AFTER THE BLOOD PRESSURE DROP WAS OBSERVED. THE PT HAD BEEN ADMITTED WITH A DIAGNOSIS OF KNEE OSTEOARTHRITIS IN 2008. 96 ML OF ROPIVACAINE WAS TO BE INFUSED OVER 48 HOURS; DOSE, RATE AND CONCENTRATION WERE NOT PROVIDED. THE PT REPORTEDLY HAD HIGH BLOOD PRESSURE (UNK LEVEL) PRIOR TO THE EVENT. THE PT'S BLOOD PRESSURE AT THE START OF THE INFUSION WAS A SYSTOLIC OF 120. REPORTEDLY, THE ROPIVACAINE INFUSED OVER 39 HOURS. ALLEGEDLY THE PT DID NOT ADMINISTER ANY BOLUS DOSES DURING THE INFUSION TIME. THE BLOOD PRESSURE WAS RESTORED TO ACCEPTABLE LEVELS. NO LABS OR SCANS WERE ORDERED BECAUSE OF THE EVENT. THE PT'S OUTCOME/STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK 80MEB MEB BAXTER HEALTHCARE 07K039

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention ANTIHYPERTENSIVE (UNK)