BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2134021 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07857
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 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). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE PATIENT REGARDING THE SYSTEM ERROR 2240 ALARM. THE PATIENT STATED SHE WAS NOT ABLE TO REMEMBER THE EVENT, HOWEVER SHE STATED THAT SHE WAS OK AND WAS ABLE TO CONTINUE THERAPY. THE PATIENT STATED THAT SHE WAS AWARE OF THE PROPER PROCEDURES. THE PATIENT STATED THAT SHE DISCARDS THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO SAMPLE WAS AVAILABLE. THIS COMPLAINT FOR A SYSTEM ERROR 2240 THAT OCCURRED DURING USE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) UNIT. THE HP STATED HER DAUGHTER HAD SET UP THE MACHINE AND NOTICED ONE OF THE SUPPLY BAGS WAS LEAKING. THE HP STATED SHE TRIED TO TIGHTEN THE CONNECTION WHILE IN THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CYCLE POWER TO CLEAR THE ALARM. THE TSR EXPLAINED THE SE ALARM INDICATES AIR ENTERED THE SET UP. THE HP STATED SHE WOULD START OVER WITH NEW SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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 63 YR HOMECHOICE