BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT

    MDR report key: 1940004 · Received December 28, 2010

    Report

    Report Number
    6000001-2010-06279
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A RUPTURED RESERVOIR. THE DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH IDC-CAPA-(B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF ONE (1) (B)(4) BASAL/BOLUS INFUSOR LV DEVICE HAD RUPTURED DURING PATIENT USE AT THE HOSPITAL. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAPANESE BASAL/BOLUS INFUSORLV 4X4 WITH 30 MIN LOCKOUT PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J067

    Patients

    Seq Age Sex Outcome Treatment
    1