BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 5-PRONG UV FLASH

    MDR report key: 1201904 · Received October 21, 2008

    Report

    Report Number
    1423500-2007-00069
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    January 16, 2007
    Report Date
    January 16, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FEB 09, 2007.

    Description of Event or Problem · 1

    REPORTERF REPORTED THAT A LEAK OCCURRED FROM THE JUNCTION OF SOLUTION BAG AND BAG LINE SPIKE. ACCORDING TO SALES REP, THIS LEAK IS DUE TO WRONG OPERATION OF NURSE. PROBLEM OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT ACCORDING TO REPORTER. PER FOLLOW UP INFORMATION RECEIVED FROM REPORTER, THE PATIENT HAD TO SET UP THERAPY WITH NEW SUPPLIES. NO FURTHER DETAILS WERE AVAILABLE PER THE INTERNATIONAL AFFILIATE, AND THE SET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 5-PRONG UV FLASH HOMECHOICE CASSETTE KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1