BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022555 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03303
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 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) A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. 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 HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING PRIMING. THE HP STATED SHE HAD STARTED OVER 3 TIMES ALREADY. THE HP STATED THAT SHE NOTICED WATER ON THE GROUND AND HER HEATER BAG WAS EMPTY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH NEW SUPPLIES. ON (B)(4) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S NURSE (RN) WHO STATED THAT THE HP HAD NOT INFORMED HER OF THE EVENT. THE RN STATED THAT THE LAST TIME SHE SPOKE WITH THE HP SHE ADVISED THE HP THAT SHE MAY NEED TO SWITCH TO CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) SINCE THE HP LIVED ALONE AND THE HC MACHINE MAY BE TOO MUCH TO HANDLE FOR HER AT THIS TIME. THE RN ADVISED THAT SHE WOULD BE FOLLOWING UP WITH THE PATIENT THAT DAY. 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 66 YR HOMECHOICE