BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122327 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07541
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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 REPORT WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H11D13051) WITH NO ISSUES NOTED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL. (B)(4) EXPLAINED THAT THE ALARM INDICATED AIR HAD ENTERED THE SETUP AND ASSISTED THE HOME PATIENT (HP) WITH ENDING THERAPY. PRODUCT SURVEILLANCE CONTACTED THE HP, WHO STATED THAT HE RESUMED THERAPY SUCCESSFULLY AFTER STARTING OVER WITH NEW SUPPLIES. THE HP ALSO STATED HE CONTACTED HIS NURSE REGARDING THE ALARM. THE PATIENT WAS INVOLVED, BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION 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 H11D13051

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR