BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2870247 · Received December 12, 2012

    Report

    Report Number
    1416980-2012-07133
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. THE ACTUAL DEFECTIVE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, HOWEVER A PHOTOGRAPH WAS AVAILABLE FOR VISUAL INSPECTION. VISUAL INSPECTION OF THE PHOTOGRAPH REVEALED THAT THE AMINO & LIPID CHAMBERS WERE ACTIVATED. NO OTHER TESTS WERE PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SENIOR PURCHASING OFFICER OF THE FACILITY REPORTED TO BAXTER (B)(4) OF A MULTILAYER BAG SET SET IN WHICH OPERATOR OBSERVED THE SEAL BETWEEN LIPID AND AMINO ACID CHAMBER WAS BROKEN UPON ARRIVAL AT HOSPITAL. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, I.V. FLUID TRANSFER KPE BAXTER HEALTHCARE - MALTA 12A31V224

    Patients

    Seq Age Sex Outcome Treatment
    1