BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2221092 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11148
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A SYSTEM ERROR 2240 ALARM WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE PATIENT DID NOT DESCRIBE ANY TYPE OF USE ERROR THAT MIGHT HAVE CAUSED THE ALARM. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    TECHNICAL SERVICE CENTER ASSISTED WITH THE SYSTEM ERROR (SE) 2240, THIS OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 1. THE HP WENT THROUGH A SERIES OF STEPS TO CLEAR THE ALARM, ALONG WITH A PROCEEDING ALARM OF SE 2367. THE CARE GIVER (CG) STATED THAT THEY WOULD START OVER WITH NEW SUPPLIES TO CONTINUE THERAPY. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THAT THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THEY STATED THEY DID CONTACT THEIR NURSE, BEFORE THEY CALLED INTO BAXTER. THE HP STATED SINCE THE REPORTED PROBLEM THERAPY OVERALL IS GOING WELL. 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 58 YR HOMECHOICE