BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4153010 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-35043
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND NO ISSUES. LEAK TESTING, CLAMP FUNCTION TESTING, CLEAR PASSAGE TESTING, AND A SIMULATED THERAPY WERE PERFORMED WITH THE DEVICE AND FOUND NO ISSUES. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H14F30016 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. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A LEAK IN THE CASSETTE ON THE HOMECHOICE DEVICE, DURING USE. THE HP WAS NOT CONNECTED AT THE TIME OF THE EVENT. THE LEAK OF THE CASSETTE WAS FURTHER DESCRIBED AS ONE OF THE UNUSED SUPPLY LINES LEAKING FLUID EVEN THOUGH THE CLAMP WAS CLOSED ON THE LINE. DURING TROUBLESHOOTING, THERE WAS NOTHING UNUSUAL NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP TO BEGIN THERAPY AGAIN WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632262 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14F30016

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR HOMECHOICE