BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1992221 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02010
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 23, 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). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DISCONNECTION OF THE SUPPLY BAG. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOME CHOICE (HC) DURING DWELL 3 OF 3. THE HP STATED SHE FOUND THAT THE FINAL BAG HAD DISCONNECTED. THE HP CONFIRMED SHE ENDED THERAPY. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE ALARM. THE HP STATED THE BAG WAS DISCARDED AND THE LOT NUMBER WAS NOT GIVEN. THE HP STATED THE BAG WAS SEPARATED FROM THE CASSETTE. THE HP STATED SHE WAS USING THE BAG WITH THE LUER CONNECTORS AT THE TIME OF THE ALARM. THE HP DID FOLLOW UP WITH HER PD RN AND NO ADVERSE EVENT RESULTED FROM THIS INCIDENT. THE HP STATED SHE RESUMED THERAPY WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE APD SYSTEM/REF (B)(4)