BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, 24 PACK,50126

    MDR report key: 1981102 · Received February 8, 2011

    Report

    Report Number
    6000001-2011-00702
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL NARRATIVE: IT IS UNKNOWN IF THIS DEVICE IS AVAILABLE FOR EVALUATION; BAXTER IS CURRENTLY ATTEMPTING TO CONTACT THIS CUSTOMER TO OBTAIN THAT INFORMATION AS WELL AS ANY ADDITIONAL INFORMATION PERTINENT TO THIS REPORT. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THE SAMPLE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "RUPTURED RESERVOIR" COULD NOT BE CONFIRMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE WILL BE IDENTIFIED/ADDRESSED THROUGH THE CAPA INVESTIGATION, (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, THE PATIENT WAS RECEIVING 250ML OF CASPOFUNGIN (UNKNOWN CONCENTRATION) 2 TIMES/DAY. EACH TIME THE PATIENT WAS ABOUT TO COMPLETE THERAPY, THE RESERVOIR RUPTURED. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT THE RESERVOIR OF ONE (1) CE INTERMATE LV250 DEVICE HAD RUPTURED DURING PATIENT INFUSION. ACCORDING TO THE CUSTOMER, AFTER MOST OF THE MEDICATION WAS INFUSED, THE INNER RESERVOIR RUPTURES MAKING A LOUD 'POPPING' NOISE AND THE REMAINDER OF THE MEDICATION IS COLLECTED IN THE HOUSING; THEREFORE, NOT ALL OF THE MEDICATION IS INFUSED. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CUSTOMER REPORTED THIS HAS HAPPENED WITH A TOTAL OF 2 INTERMATES WITH THE SAME PATIENT (PATIENT B). THS IS REPORT 1 OF 2 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY FOR ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 250, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10C046

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR CASPOFUNGIN