BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    MDR report key: 2063664 · Received April 20, 2011

    Report

    Report Number
    6000001-2011-03001
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "RESERVOIR RUPTURED" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA# (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF A RUPTURED RESERVOIR ON ONE (1) BASAL/BOLUS INFUSOR 2ML DEVICE. THIS OCCURRED DURING PATIENT USE AT THE HOSPITAL. THE PATIENT WAS BEING INFUSED WITH 20ML FENTANYL CITRATE, 72ML OF 20.2% ROPIVACAINE HYDROCHLORIDE HYDRATE AND 8ML OF 30.75% ROPIVACAINE HYDROCHLORIDE HYDRATE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED WITH THIS EVENT. THERE WAS PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10M035

    Patients

    Seq Age Sex Outcome Treatment
    1 FENTANYL CITRATE| 30.75% ROPIVACAINE HYDROCHLORIDE HYDRATE| 20.2% ROPIVACAINE HYDROCHLORIDE HYDRATE