BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1942821 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07420
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 13, 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 ACTUAL SAMPLE IS NOT AVAILABLE, BUT A COMPANION SAMPLE IS AND HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FOR A CONNECTION ISSUE - DISCONNECTION OF A SUPPLY BAG. THIS REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. FROM THE DATA WITHIN THE REPORT, THE ROOT CAUSE WAS NOT IDENTIFIED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM ON THE HOME CHOICE (HC) DURING FILL 2 OF 4 WITH A FILL VOLUME OF 148ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO PRESS STOP/GO TO CLEAR THE ALARM AND RESUME FILL. THEY CHECKED THE PATIENT LINE AND FOUND NO KINKS, CLOSED CLAMPS OR FIBRIN. THEY CLOSED AND OPENED THE TRANSFER SET, REMOVED THE TAPE FROM THE PATIENT LINE THEN REPOSITIONED THE HP. THE ALARM REPEATED SEVERAL TIMES SO THE TSR ASSISTED WITH END OF THERAPY EARLY PROCEDURE. THE HP WOULD COMPLETE THERAPY VIA MANUAL SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010. THE PATIENT STATED THE FOLLOWING: THE ALARM WAS CAUSED BY A DISCONNECTION OF THE SUPPLY BAG. THE SPIKE HAD BEEN CHECKED AND WAS IN GOOD PRIOR TO THE CONNECTION OF THERAPY. THE SAMPLES WERE DISCARDED BUT A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED FOR THE CASSETTE. THE LOT NUMBER FOR THE CASSETTE WAS H10I08010. THE NURSE WAS CONTACTED REGARDING THE EVENT AND SHE HAD THE PATIENT DO 3 MANUAL EXCHANGES THE NEXT DAY AND CHECK FOR CLOUDINESS. THE BAGS WERE NOT CLOUDY AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 H10I08010

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR PD CYCLER