BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240610 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11923
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DRAIN 3 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ASSIGNABLE CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING DRAIN 3. PER THE INITIAL REPORT, HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN THE LINE). THE HP STATED THAT THE LINES APPEARED TO BE FINE. THERE WERE EMPTY BAGS AND THE UNUSED LINES WERE CLAMPED. THE TSR HAD THE HP CYCLE THE POWER TO DISPLAY PRESS GO TO START. THE HP WOULD FINISH WITH MANUAL SUPPLIES AND NOTIFY THE PERITONEAL DIALYSIS NURSE OF THE ALARM. GLOBAL PRODUCT SURVEILLANCE CONTACTED HP ON (B)(6) 2011. THE HP STATED THAT SHE TURNED THE HC OFF AND DID NOT ATTEMPT TO CONTINUE THERAPY. 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 79 YR HOMECHOICE