BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SINGLEDAY 2ML/HR 12PK

    MDR report key: 1761272 · Received July 19, 2010

    Report

    Report Number
    6000001-2010-01754
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE CUSTOMER, THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF A RUPTURED RESERVOIR CANNOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE FOR RUPTURED RESERVOIRS EXPERIENCED ON COILED TUBE INFUSOR DEVICES IS CURRENTLY BEING INVESTIGATED UNDER CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A SINGLE DAY INFUSOR DEVICE RUPTURED APPROXIMATELY HALF WAY THROUGH A PATIENT CHEMOTHERAPY TREATMENT. THE DEVICE WAS INFUSING 5-FLUOROURACIL WHEN THE RUPTURE OCCURRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A SINGLE DAY INFUSOR DEVICE RUPTURED APPROXIMATELY HALF WAY THROUGH A PATIENT CHEMOTHERAPY TREATMENT. THE DEVICE WAS INFUSING 49 ML OF 5-FLUOROURACIL WITH A PHYSIOLOGIC SOLUTION WHEN THE RUPTURE OCCURRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SINGLEDAY 2ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1