BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASAL/BOLUS INFUSOR, 12 PACK0.5ML/H X 1H

    MDR report key: 2073553 · Received May 2, 2011

    Report

    Report Number
    6000001-2011-03343
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE CONFIRMED A RUPTURED RESERVOIR. NO OTHER OBSERVATION WAS NOTED ON THE SAMPLE. A TIER II CORRECTIVE AND PREVENTIVE ACTION (CAPA), (B)(4) WAS OPENED TO INVESTIGATE THE ROOT CAUSES THAT LED TO THIS FAILURE MODE. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) BASAL/BOLUS INFUSOR, 12 PACK 0.5ML/H DEVICE REPORTEDLY RUPTURED DURING PATIENT USE AT THE HOSPITAL. IT IS UNKNOWN WITH WHAT THE DEVICE WAS FILLED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASAL/BOLUS INFUSOR, 12 PACK0.5ML/H X 1H PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 08N008

    Patients

    Seq Age Sex Outcome Treatment
    1