BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3130216 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13382
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K090096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. EVALUATION: ONE UNUSED UNIT FROM THE SAME LOT NUMBER WAS AVAILABLE AT THE PLANT FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE UNIT WAS FILLED WITH SOLUTION AND A SPIKE FROM AN EXTENSION SET WAS INSERTED TO THE UNIT. UNIT WAS HANGED IN THE HOOK AND THE SET WAS PRIMED. UNIT DOES NOT FAIL TO THE FUNCTIONAL TEST. UNIT WAS ALSO TESTED TO CLEAR PASSAGE AT 8PSI AND PRESSURE TEST AT 8PSI, RESULTING SATISFACTORY RESULT TO BOTH TESTS. UNIT WAS WORKING WITHIN SPECIFICATION. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALL-IN-ONE EMPTY CONTAINER WAS LEAKING FROM SEVERAL SMALL CUTS NEAR THE BOTTOM OF THE BAG, ABOVE THE PORTS. THE BAG HAD BEEN FILLED WITH MILRINONE AND WAS TRANSPORTED TO THE PATIENT. THE LEAK WAS IDENTIFIED WHEN THE BAG WAS HOOKED UP TO THE PATIENT. NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231915 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR12J24139

    Patients

    Seq Age Sex Outcome Treatment
    1 MILRINONE| UNKNOWN PUMP