BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2040232 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04124
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 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). A COMPANION SAMPLE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER EVALUATION HAS NOT BEEN STARTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A CHECK PATIENT LINE (CPL) ALARM. ORIGINAL SAMPLE WAS DISCARDED BUT A COMPANION SAMPLE WAS RETURNED. THE COMPLAINT WAS NOT CONFIRMED IN THE LAB. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT THERE WERE LARGE GAPS OF AIR IN THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR WALKED THE HP THROUGH ENDING THERAPY EARLY PROCEDURE. THE HP ENDED THERAPY AND WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. DURING FOLLOW UP, THE HP STATED THAT SHE DID NOT KNOW HOW THE AIR GOT IN THE PATIENT LINE. THE HP DID NOT NOTE ANYTHING UNUSUAL WITH THE SUPPLIES THEY WERE USING THAT NIGHT. THE HP DID LET THEIR REGISTERED NURSE (RN) KNOW ABOUT THE INCIDENT. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO 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 H10J22093

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE CYCLER