BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1902225 · Received November 18, 2010

    Report

    Report Number
    1423500-2010-05929
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 3 OF 4. GTS EXPLAINED THE ALARM. THE HOME PATIENT (HP) DID NOT DISCONNECT. THERE WERE NO LEAKS. THERE WERE NO UNUSED LINES. GTS ASSISTED THE HP WITH RETRIEVING THE CASSETTE. GTS ADVISED THE HP TO LET HIS REGISTERED NURSE (RN) KNOW ABOUT THE ALARM. THE HP WAS GOING TO FOLLOW UP WITH MANUAL EXCHANGES. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP'S DIALYSIS RN. THE RN STATED THE HP HAD NOTIFIED HER. THE NURSE STATED THE HP DID NOT EXPERIENCE ANY INJURY OR MEDICAL INTERVENTION AND THE ONLY THING HE DID DIFFERENTLY WAS USE ULTRABAGS TO COMPLETE THERAPY. THE HP THEN RESUMED THERAPY ON THE CYCLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME 660492

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR