BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2103491 · Received May 26, 2011

    Report

    Report Number
    6000001-2011-04685
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 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: PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE RESULTS OF EVALUATION COULD NOT BE COMPLETED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. 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: NO SAMPLE, PICTURE OR LOT NUMBER WAS PROVIDED TO PERFORM AN EVALUATION. HOWEVER, THIS TYPE OF FAILURE HAS BEEN SEEN PREVIOUSLY AND POTENTIAL ROOT CAUSES WERE IDENTIFIED. A TIER II CORRECTIVE AND PREVENTIVE ACTION (CAPA), IM-CAPA-(B)(4) WAS OPENED TO INVESTIGATE THE ROOT CAUSES THAT LED TO THIS FAILURE MODE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) INFUSOR TWO DAY 2ML/HR DEVICE HAD A RUPTURED RESERVOIR DURING FILLING.'THE USED DRUG WAS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS NO PATIENT INVOLVEMENT. THE ACTUAL SAMPLE IS AVAILABLE.' NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1