BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1843087 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03670
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED, AND THE LOT NUMBER WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE HOME PATIENT (HP) DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE HP HAD DISCONNECTED PRIOR TO THE ALARM, AND THEN RECONNECTED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) DURING DRAIN CYCLE 1. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP HAD DISCONNECTED PRIOR TO THE ALARM, THEN RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND TROUBLESHOOTING THE ALARM. THE TSR SUGGESTED STARTING OVER WITH NEW SUPPLIES. THE HP STATED HE WAS GOING TO END THERAPY AND THAT HIS NURSE WOULD COME IN THE MORNING TO DO A DAY EXCHANGE. THE TSR ASSISTED WITH ENDING THERAPY AND HP WOULD START OVER WITH NEW SUPPLIES IN THE MORNING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN FOUND THAT A HOMECHOICE SYSTEM FAILED THE THE GROUND BOND PERFORMANCE SPECIFICATION DURING TESTING.

    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