BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240653 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11930
    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). THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DWELL 4/5 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.

    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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 5. PER THE INITIAL REPORT, HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN THE LINE). THERE WAS NO HP OR BAG DISCONNECTION. THERE WERE NO LOOSE CONNECTIONS OR LEAKS. THE TECHNICAL SERVICE REPRESENTATIVE REFERRED THE HP TO THE NURSE (RN). GLOBAL PRODUCT SURVEILLANCE CONTACTED HP ON (B)(4) 2011. THE HP STATED THAT HE WAS UNABLE TO COMPLETE THERAPY. THE HP WAS IN THE HOSPITAL AND DID NOT HANDLE THE SETUP OR TAKE DOWN OF THE HC. THE HP STATED THAT THE HOSPITAL STAY WAS NOT DUE TO PERITONEAL DIALYSIS. 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 65 YR HOMECHOICE