BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183525 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09969
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A LEAK WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING FINDING LIQUID UNDER THE MACHINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE AT THE END OF THERAPY. THE PATIENT WAS CONNECTED. THE MEMBRANE INSIDE THE DOOR APPEARED TO BE DAMP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SWAPPED THE MACHINE FOR THE LEAK AND THE MEMBRANE BEING WET BEHIND THE CASSETTE. THE REGISTERED NURSE (RN) WOULD PROGRAM THE NEW HC. THE PATIENT WOULD CONTACT THE RN REGARDING THE STERILITY ISSUE WITH THE LEAK AND HAVING BEEN CONNECTED. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AGAIN THE SAME DAY TO REPORT THAT THEY FOUND THAT THE BAG HAD BEEN LEAKING. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED LEAK. THE PATIENT STATED THAT THE TSR HAD THEM FEEL THE INSIDE OF THE MACHINE AND IT FELT WET AND THE LINES ON THE CASSETTE FELT WET. THE PATIENT DID NOT KNOW IF THERE WAS ANY ISSUE WITH THE CASSETTE BUT THE HEATER BAG WAS FOUND TO BE LEAKING. THE PATIENT NOTICED THERE WAS A LEAK COMING FROM THE TOP OF THE BAG AND BROUGHT THE SAMPLE INTO THEIR DIALYSIS CENTER FOR THE NURSE TO LOOK AT. THE PATIENT STATED SINCE THEN THERAPY HAD BEEN GOING FINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER PRODUCT SURVEILLANCE CONTACTED THE RN REGARDING REPORTED LEAK. THE RN STATED WHEN THEY LOOKED AT THE SAMPLE THERE APPEARED TO BE A TINY HOLE IN THE BAG. THE RN STATED THE HOLE LOOKED LIKE IT MIGHT HAVE BEEN CAUSED BY A NEEDLE PUNCTURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR HOMECHOICE PRO