BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2012065 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02940
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 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 SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H11A11051) WITH NO ISSUES NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240. THIS SITUATION OCCURRED DRAIN 3 OF 4. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE MESSAGE TO THE HOME PATIENT (HP) AND ASKED THE HP TO LET THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) KNOW. THE TSR INSTRUCTED THE HP TO RECYCLE THE MACHINE AND AN SE 2367 OCCURRED. THE TSR INFORMED THE HP TO USE A MANUAL BAG. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE HP STATED THAT THE LINE WAS LEAKING SOLUTION THAT NIGHT AS SHE HAD A PUDDLE ON THE FLOOR. THE HP STATED SHE WENT INTO THE HOSPITAL ON (B)(6) AS SHE WAS BLOATED. THE HP STATED SHE WAS CURRENTLY ON HEMO DIALYSIS. THE HP DID NOT KNOW THE REASON FOR THE BLOATING.

    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 H11A11051

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4) EXTRANEAL, SINGLE BAG (B)(4) ICODEXTRIN