BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1905080 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06099
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 31, 2010
    Report Date
    October 31, 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 IS FOR A REPORT OF THE PATIENT DISCONNECTING AND NOT CAPPING THE PATIENT LINE. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN, THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE WAS UNDETERMINED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).SAMPLE IS NOT AVAILABLE FOR EVALUATION AND LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING REQUESTING ASSISTANCE TO END THE THERAPY WHILE ON THE HOMECHOICE DEVICE. THE HOME PATIENT (HP) DISCONNECTED TO USE THE BATHROOM AND DID NOT HAVE A CAP ON THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED TO END THE THERAPY AS REQUESTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. FOLLOW UP WITH THE HOMEPATIENT REVEALED THAT HE INFORMED HIS NURSE OF THE SITUATION AND HE IS DOING FINE. THE HP STATED THAT HE IS CONTINUING WITH THERAPY WITHOUT ANY PROBLEMS. THE HP CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR