BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1962541 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00713
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 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). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA(B)(4). A FOLLOW-UP REPORT WILL BE FILED, SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS LEFT IN THE SWAPPED OUT HOMECHOICE UNIT AND THEN DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 4 OF 4. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP TURN OFF THE MACHINE, THEN BACK ON. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL TO THE HOME PATIENT (HP) SHE STATED THAT SHE WAS ABLE TO CONTINUE THERAPY WITH MANUAL SUPPLIES, THERE WAS NO ADVERSE EVENT, SHE WAS FINE AND THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR HOMECHOICE CYCLER