BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1983777 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01736
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 15, 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). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK DRAIN LINE ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 2. THE DRAIN VOLUME (DV) EQUALED 41ML. THE LAST FILL VOLUME (LFV) EQUALED 1900ML. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP WITH TROUBLESHOOTING. THE HP STATED THE ALARM REPEATED. THE TSR ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR FURTHER ADVISED IF THE ALARM REPEATED TO CALL BACK. THE TSR ASSISTED THE HP TO END THERAPY. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP WHO CONFIRMED THAT AFTER STARTING OVER WITH NEW SUPPLIES, SHE WAS ABLE TO COMPLETE THERAPY. THE HP STATED THAT SHE NOTICED SOME AIR BUBBLES IN THE LINES NEAR THE DOOR. THE HP CONFIRMED THERAPY HAS CONTINUED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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 H10K18081

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE APD SYSTEM/REF (B)(4)