BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2230377 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11511
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 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). THIS COMPLAINT WAS FOR A SYSTEM ERROR 2240 ALARM DURING FILL WAS CONFIRMED AS A USE ERROR BASED ON INFORMATION PROVIDED BY THE HOME PATIENT (HP) AND CARE GIVER (CG). IT WAS REPORTED THAT THE CG DISCONNECTED THE HEATER BAG DURING THE LAST FILL AS CG THOUGHT THE HP WAS DONE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING ASSISTANCE WITH A SYSTEM ERROR (SE) 2240 ON THE HOME CHOICE (HC), DURING USE, DURING LAST FILL; THE HOME PATIENT REVEALED THAT THE CARE GIVER HAD ACCIDENTLY DISCONNECTED THE HEATER BAG BEFORE THERAPY WAS COMPLETED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH THE TROUBLE SHOOTING. THERAPY WAS ENDED. DURING A FOLLOW-UP WITH THE CARE GIVER (CG) REGARDING THE REPORTED PROBLEM, THEY STATED THE PATIENT JUST ENDED THERAPY FOR THE NIGHT SINCE THEY WERE IN THEIR LAST FILL. THEY HAVE NOT TALKED TO THEIR NURSE YET, BUT WILL CONTACT THEM SHORTLY. THE CG STATED THE HOME PATIENT (HP) HAS BEEN CONTINUING THERAPY FINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 77 YR HOMECHOICE