BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1971189 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01059
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    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 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 PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240 WHICH OCCURRED DURING DWELL 1. THE HOME PATIENT (HP) STATED THAT HE HAD DISCONNECTED TO USE BATHROOM AND RECONNECTED AND MAY HAVE FORGOTTEN TO PRESS STOP BEFORE DISCONNECTING. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO CONTACT THE NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP, THE HP STATED THAT WHEN HE DISCONNECTED TO USE THE RESTROOM, HE DID NOT PRESS STOP AND WHEN HE RECONNECTED, HE RECEIVED THE ALARM. THE HP WAS AWARE OF THE CORRECT DISCONNECT PROCEDURE. THE HP DID NOT CONTACT THE NURSE. THE HP WAS ADVISED TO CONTACT THE PERITONEAL DIALYSIS NURSE TO LET HER KNOW ABOUT THE ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 33 YR HOMECHOICE CYCLER