BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192511 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10308
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 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). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION, THEREFORE, THE SAMPLE WAS NOT REQUESTED AND A BATCH REVIEW WILL NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USER ERROR - FAILED TO FOLLOW THERAPY STEPS WAS NOT CONFIRMED. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. THE CAUSE WAS THE PATIENT DID NOT PROPERLY DISCONNECT FROM THE HOMECHOICE SYSTEM. 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 (TSC) BECAUSE THE CAREGIVER (CG) FOUND THAT THE HOME PATIENT (HP) HAD DISCONNECTED FROM HOMECHOICE (HC). THE CG STATED THAT SHE FOUND THE PATIENT LINE ON THE FLOOR WITH NO CAP ON THE LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH END OF THERAPY EARLY PROCEDURE. THE CG WAS ADVISED TO NOTIFY PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) AS SOON AS POSSIBLE. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) ON (B)(6) 2011 REGARDING THE PATIENT LINE DISCONNECTING. THE CG STATED THAT THE HOME PATIENT (HP) HAD DISCONNECTED HIMSELF FROM THE PATIENT LINE DURING DRAIN AND THE PATIENT LINE FELL ON THE FLOOR. THE CG SAID THAT SHE HAD RECONNECTED THE HP TO THE PATIENT LINE. WHILE THE HP WAS IN DRAIN THE CG CALLED GLOBAL TECHNICAL SERVICES BEFORE DRAIN ENDED. THE CG STOPPED THE DRAIN. THE CG SAID THAT THERE WERE NO ALARMS. THE HP WAS IN DRAIN 3 OF 4. THE CG CONTACTED THE HP'S NURSE AND THE HP WAS GIVEN ANTIBIOTICS AS A PREVENTATIVE. THE HP DID NOT RECEIVE ANY INJURY AS A RESULT OF THIS INCIDENT. THE CG STATED THAT THE HP WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    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