BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3083348 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10710
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER'S ATTEMPTS TO OBTAIN THE SAMPLE AND LOT NUMBER WERE UNSUCCESSFUL. THEREFORE, AN EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CURRENT EVALUATION CODES NO LONGER APPLY AS THE DEVICE HAS BEEN RECEIVED AND EVALUATED. UPON COMPLETION OF BAXTER'S EVALUATION, NEW CODES WILL BE SUBMITTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR LOT NUMBER H12H26053 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. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND CRAZING WAS NOTED AFTER A LEAK WAS DETECTED. LEAK TESTING WAS PERFORMED AND A CASSETTE LEAK WAS NOTED. MEASUREMENT OF THE LEAK RATE WAS FOUND TO BE BELOW SPECIFICATION. CLEAR PASSAGE TESTING AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES. THE DEVICE WAS RUN ON A LAB HOMECHOICE (HC) MACHINE WITH NO ISSUES. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A LEAK IN A CASSETTE THAT OCCURRED ON THE HOME CHOICE (HC) DURING FILL 4 OF 9. PER THE HOME PATIENT (HP), THE CASSETTE LEAKED DURING THERAPY, WHILE HE WAS CONNECTED AND THE HP POWERED OFF THE MACHINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT AND HE SAID HE DID NOT NOTICE ANYTHING WRONG WITH THE SUPPLIES THAT DAY AND WHEN HE REMOVED THE CASSETTE HE COULD NOT DETERMINE WHERE THE LEAK WAS COMING FROM. SINCE THEN HE HAS BEEN COMPLETING THERAPY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183397 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE