BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243315 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12057
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 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 AIR BUBBLES IN THE PATIENT LINE DURING THE INITIAL DRAIN AND THE HOMECHOICE (HC) ALARMED CHECK PATIENT LINE, WAS NOT CONFIRMED AS AIR BUBBLES IN THE PATIENT LINE WOULD NOT CAUSE THE ALARM. THE CAUSE WAS UNDETERMINED. 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 NCR NUMBER (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, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING AIR BUBBLES IN THE PATIENT LINE WHILE ALARMING CHECK PATIENT LINE DURING THE INITIAL DRAIN WHILE ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CAREGIVER (CG) TO CHECK THE LINE FOR KINKS, CLAMPS AIR AND FIBRIN. THERE WERE SOME AIR BUBBLES IN THE PATIENT LINE, SOME WERE LARGER. THE TSR ASSISTED WITH ENDING THERAPY ON THE CYCLER SO THAT THE CG COULD SET UP WITH NEW SUPPLIES. THE PERITONEAL DIALYSIS NURSE (PDRN) CONTACTED PRODUCT SURVEILLANCE (PS) ON (B)(6) 2011 REGARDING THE CHECK PATIENT LINE ALARM WITH AIR BUBBLES IN THE LINE. PER THE PD RN, SHE SAW THE HP TODAY AND SHE DID NOT MENTION ANYTHING TO HER ABOUT THE ALARM OR AIR. THE PD RN STATED THE HP HAS RESUMED THERAPY ON THE CYCLER. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE