BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2250263 · Received September 15, 2011

    Report

    Report Number
    1423500-2011-12281
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 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 COMPLAINT FOR A CHECK LINES AND BAGS ALARM WAS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE PATIENT. THE USER RECONNECTED AND DISCONNECTED THE LINE DURING THERAPY. THE LABELING PROVIDED IN THE PATIENT GUIDE WAS FOUND TO BE SUFFICIENT AND ACCESSIBLE TO THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A LEAK IN THE HEATER BAG DURING CHECK LINES AND BAGS ALARM WHILE PRIMING ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED HE CONNECTED IT BETTER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE HP WOULD HAVE TO START OVER WITH ALL NEW SUPPLIES. THE TSR HAD THE HP CLOSE THE CLAMPS AND CYCLE THE POWER. THE HP STATED HE WAS USING THE SPIKED SET AND THE HC WENT TO PRESS GO TO START. THE TSR ASSISTED THE HP WITH GETTING THE SET OUT AND EXPLAINED THE HP CAN START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(4) 2011 REGARDING THE CHECK LINES AND BAGS ALARM WHERE THE SOLUTION BAG WAS LEAKING. THE HP STATED THEY STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY. THE HP IS AWARE OF THE PROPER SETUP PROCEDURES AND THAT THE SUPPLIES SHOULD NOT BE USED WHEN LEAKING. THE HP STATED HE FOLLOWED UP WITH HIS PERITONEAL DIALYSIS NURSE (PDRN) REGARDING THE ALARM AND LEAK. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR HOMECHOICE