BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2140405 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08916
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED CONDITION FOR RUPTURED CANNOT BE CONFIRMED SINCE NO PICTURE OR SAMPLE WAS AVAILABLE FOR EVALUATION. 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 RECEIVED A CALL STATING THAT THREE (3) TWO DAY INFUSOR DEVICES RUPTURED DURING FILLING. THE DEVICES WERE BEING FILLED WITH 5-FLUOROURACIL AND SALINE. THIS OCCURRED PRIOR TO PATIENT CONNECTION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. THIS WILL REFERENCE REPORT 2 OF 3 FOR THE FACILITY. PER THE CUSTOMER, THE SAMPLES ARE NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11D007

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| 5-FLUOROURACIL