BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2081822 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05625
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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). THIS REPORT WAS NOT CONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. 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

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING DWELL 3 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER TO CLEAR THE ALARM. THE TSR EXPLAINED THE SE 2240 ALARM INDICATED AIR ENTERED THE SET UP. THE HP CONFIRMED THERE WAS NO OBVIOUS CAUSE FOR THE ALARM. THE HP STATED THE SUPPLY BAG WAS EMPTY. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL AND ADVISED THE HP TO CALL THE NURSE TO INFORM OF THE EVENT. ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE CARE GIVER (CG) WHO STATED THE HP FINISHED THERAPY THE FOLLOWING MORNING USING MANUAL SUPPLIES. THE CG STATED THE REGISTERED NURSE (RN) WAS INFORMED. THE CG STATED THERAPY HAS RESUMED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE