BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3- PRONG

    MDR report key: 1201223 · Received October 20, 2008

    Report

    Report Number
    1423500-2007-00026
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 16, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 22, 2007.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER AND REPORTED THAT SHE HAS HAD APPROXIMATELY 9 CASSETTES WITH LEAKING PATIENT LINES IN APPROXIMATELY THE LAST 3 WEEKS. THE LEAKS OCCURRED DURING PRIME NEAR THE PATIENT CONNECTOR. HP WAS ABLE TO RESTART AND COMPLETE THERAPY EACH TIME WITH NEW SUPPLIES. THE PATIENT LINE AND SOLUTION BAG ARE ON AN EVEN LEVEL. THE HP NOTED THE LEAK VISUALLY. THE HP THEN RECEIVED UNSPECIFIED RELOAD CASSETTE ALARMS. PETS DO NOT HAVE ACCESS TO THE HP'S SUPPLIES. THERE WAS NO DAMAGE NOTED TO THE BOX IN WHICH THE CASSETTES WERE RECEIVED. HP DOES NOT USE SHARP OBJECTS TO OPEN THE BOX OF CASSETTES. THE HP DID NOT NOTIFY BAXTER TECHNICAL SERVICES OR HER NURSE OF THESE EVENTS. SAMPLES WERE DISCARDED. PER THE HP, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3- PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION H06J18063

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT| LOW CALCIUM DIANEAL SOLUTION STRENGTH UNKNOWN| 15 LITER DRAINAGE BAG| CAPD TRANSFER SET