BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3250606 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19918
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. THE INITIAL INVESTIGATION CONFIRMED THE REPORTED ISSUE BECAUSE A VISUAL INSPECTION WAS PERFORMED AND IT IDENTIFIED DAMAGE TO THE SLEEVE AND THE MAINBODY. LEAK TESTING, CLEAR PASSAGE TESTING AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR THIS PRODUCT WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CRACK IN THE BLUE PART OF THE TRANSFER SET. THIS OCCURRED WHILE THE HOME PATIENT (HP) WAS CONNECTED TO THE HOMECHOICE (HC) DEVICE FOR THERAPY. THE TRANSFER SET WAS REPLACED AND THE HP CONTINUED THEIR TREATMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350544 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12C29058

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE