BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2091869 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04153
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 28, 2011
    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). 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). 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) INFUSOR DEVICE HAD A RESERVOIR RUPTURE DURING PATIENT USE AT THE HOSPITAL. SIXTY CC OF DRUG REMAINED IN THE RESERVOIR AFTER THE RUPTURE. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND SALINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K108

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| SALINE