BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073280 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05231
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 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 OF USE ERROR (REUSE OF SINGLE USE SUPPLIES) WAS CONFIRMED BASED ON THE USER'S REPORT THAT THE DISPOSABLE SET, BUT NOT THE SOLUTION BAGS, WAS CHANGED FOLLOWING AN ALARM. THE CAUSE OF THE USE ERROR IS UNKNOWN. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM (SEE MASTER COMPLAINT) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING PRIME. THE HOME PATIENT (HP) STATED THEY CHANGED THE CASSETTE AND THE ALARM WAS STILL OCCURRING. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF THEY CHANGED OUT THE BAGS ALSO, THEY STATED NO ONLY THE CASSETTE. THE TSR EXPLAINED THAT THEY HAD COMPROMISED THE SET UP AND SHOULD ALWAYS CHANGE OUT EVERYTHING WHEN THEY HAVE TO CHANGE OUT ONE ITEM. THE TSR CONFIRMED WITH THE HP THAT THE FRANGIBLE HAD BEEN BROKEN, THEY MOVED THE WHITE CLAMP 6 INCHES EITHER DIRECTION, INSPECTED THE BAG PORT, THEN FLIPPED THE SUPPLY BAG OVER. THE TSR HAD THE HP PRESS STOP AND GO, THE HC ALARMED AGAIN. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS WRITER CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP STATED THAT THEY DO NOT KNOW WHY THEY KEPT GETTING THE CHECK SUPPLY LINE ALARM, SO THEY STARTED OVER. THE HP STATED THAT THEY KNEW WHAT THEY DID WRONG, AFTER THEY STARTED OVER AND THE ALARM REPEATED. THE HP STATED THE FIRST WAS UNKNOWN, BUT THE SECOND TIME THE ALARM HAPPENED IT WAS THEIR FAULT. THE HP STATED THEY DO NOT KNOW THE LOT NUMBER, AND THEY DISCARDED SAMPLE. THE HP STATED THERAPY HAS BEEN GOING GOOD OTHERWISE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME NI

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER