BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3891400 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20066
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED 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. A VISUAL INSPECTION OF THE SAMPLE IDENTIFIED A TEAR IN THE CASSETTE SHEETING. FUNCTIONAL LEAK TESTING WAS PERFORMED AND IDENTIFIED A LEAK ORIGINATING FROM THE SHEETING WELD. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED LEAK WAS DUE TO A PUNCTURE OR TEAR IN THE CASSETTE SHEETING. IT WAS UNKNOWN WHAT CAUSED THE TEAR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS AND AN EVALUATION IS ANTICIPATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CASSETTE LEAKED WHILE A PATIENT WAS PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT STATED THAT WHEN THE CASSETTE WAS REMOVED AFTER THERAPY, THE PATIENT OBSERVED LEAKING AROUND THE JUNCTION WHERE THE LINES CONNECTED TO THE CASSETTE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION INDICATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368322 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14A14086

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE