BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2002400 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02509
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USER ERROR. THE PATIENT REPLACED THE CASSETTE HOWEVER REUSED THE SOLUTION BAGS. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. 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. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME. THE HOME PATIENT (HP) STATED THAT SHE RESET-UP BUT ONLY CHANGED HER CASSETTE AND WAS STILL UNABLE TO PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP RESET-UP AGAIN DUE TO THE FACT THAT THE HP CHANGED ONLY THE CASSETTE AND NOT THE SUPPLY BAGS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW-UP WITH THE REPORTING NURSE, SHE SAID THAT SHE THOUGHT SHE MIGHT HAVE PINCHED THE PORT OF THE BAG TOO HARD BECAUSE THE SOLUTION WOULD NOT FLOW OUT, AND WHEN SHE WENT TO GRAB IT SHE PINCHED IT TOO TIGHT. THE NURSE SAID THAT THE PATIENT RESUMED THERAPY WITH THE NEW SUPPLIES AND DID NOT HAVE ANY COMPLICATIONS. THE PATIENT INFORMATION WAS UNKNOWN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 HC CYCLER