BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2525046 · Received April 10, 2012

    Report

    Report Number
    1423500-2012-08396
    Event Type
    Malfunction
    Date Received
    April 10, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS THE RESULT OF A USE ERROR; THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. FOR THIS REASON, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED.THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE (CHL) ALARM. THE HOME PATIENT (HP) STATED IN HIS ATTEMPT OF RESOLVING THE CHL ALARM IN FILL 1 HE HAD REPLACED THE CASSETTE THREE TIMES BUT NOT THE BAGS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THE HEATER BAG WAS THE CAUSE OF THE CHL ALARM. THERE WAS RESTRICTED FLOW AT THE NECK OF THE BAG AND THE HP NEEDED TO REPLACE NOT JUST THE CASSETTE BUT ALL THE SUPPLIES. THAT WOULD KEEP THE HP SAFE FROM OUTSIDE AIR HAVING GOTTEN INTO THE SUPPLIES. THE CALL ENDED. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOME CHOICE