BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3212889 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17807
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION AND A FUNCTIONAL LEAK TEST WERE PERFORMED ON THE DEVICE. IT WAS DETERMINED THAT THERE WAS A LEAK AT THE PORT TUBE SEAL. THE CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE. AS A RESULT, CORRECTIVE MAINTENANCE OF THE MACHINES WAS IMPLEMENTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3 LITER EVA BAG LEAKED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314135 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - CALI SX13DG2

    Patients

    Seq Age Sex Outcome Treatment
    1