BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1962113 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00699
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE HP STATED SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. PER THE HP, THERE WAS NO DISCONNECTION OR LOOSE CONNECTIONS THAT MAY HAVE CAUSED THE ALARM TO OCCUR. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4), A BATCH REVIEW WILL NOT BE PERFORMED BECAUSE, THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES TO REPORT A SYSTEM ERROR (SE) 2367 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO CYCLE POWER TO CHECK THE ALARM LOG. THE CG CONFIRMED A SE 2240 WAS THE PRIOR ALARM. THE TSR ADVISED THE CG TO DISCONNECT THE HOME PATIENT (HP) AND RESTART THE SETUP WITH ALL NEW SUPPLIES. THE CG STATED THAT THERE WERE NO PROBLEMS WITH THE SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) WHO CONFIRMED SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP CONFIRMED THERE WAS NO DISCONNECTION OR LOOSE CONNECTIONS THAT MAY HAVE CAUSED THE ALARM. THE HP STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE APD SYSTEM (B)(4) REFURBISHED