BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1983705 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01728
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 19, 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). THE REPORTED CONDITION WAS NOT CONFIRMED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITION WAS USER ERROR/MIS USE. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO E ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE ALARM THAT OCCURRED ON THE HOMECHOICE (HC) DURING FILL 1. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CHECK FOR BROKEN SEALS AND OPEN CLAMPS. THE HP STATED THE DRAIN LINE WAS USED FOR OVER TWO WEEKS. THE HP STATED SHE WOULD REPLACE THE LINE ON THE NEXT SETUP. THE HP FURTHER REPORTED THE ALARM REPEATED. THE HP ELECTED TO REPLACE THE SETUP WITH NEW CASSETTES AND BAGS. ON (B)(4) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED SHE WAS ABLE TO RESUME THERAPY AFTER STARTING OVER WITH THE NEW SUPPLIES. THE HP DID NOT NOTICE ANYTHING WRONG WITH THE CASSETTE. THE HP DISCARDED THE SAMPLE AND DID NOT PROVIDE THE LOT NUMBER. THE HP WAS USING THE NEW LUER TWISTING CASSETTE. THE HP WAS CONTINUING THERAPY WITHOUT ANY COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION 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 57 YR HOMECHOICE PRO APD CYCLER ((B)(4))