BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2032744 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03784
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 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). SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING AN ALARM ON THE HOMECHOICE (HC) MACHINE DURING DRAIN OF THE PREVIOUS THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH REVIEWING THE ALARM LOG. A SYSTEM ERROR 2240 (AIR IN LINE) ALARM HAD OCCURRED. THE TSR EXPLAINED THE POSSIBLE CAUSES AND ADVISED TO NOTIFY THE NURSE OF THE ALARM. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S WIFE ON (B)(6) 2011. ACCORDING TO THE PATIENT'S WIFE, THEY DID NOT OBSERVE ANY HOLES, LEAKS, OR DEFECTS IN THE SUPPLIES WHEN THE ALARM HAD OCCURRED. THE WIFE STATED THAT THEY HAVE RESUMED THERAPY. PRODUCT SURVEILLANCE ADVISED TO CALL SHOULD THEY HAVE ANY ISSUES. NO FURTHER INFORMATION IS AVAILABLE. 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 77 YR HOMECHOICE