BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022640 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03328
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 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 SAMPLE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED. THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) REPORTED A SYSTEM ERROR (SE) 2367 IN DRAIN 4 OF 6. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM LOG AND FOUND A SE 2240. THE TSR FOUND THAT THE HP DISCONNECT HIMSELF AND STATED IT WAS POSSIBLE HE DID NOT PRESS STOP. THE HP WOULD CONTINUE WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HOME PATIENT WAS CONTACTED ON (B)(6) 2011. THE HOME PATIENT CONFIRMED HE RE-CONNECTED AFTER THE ALARM OCCURRED. THE HOME PATIENT STATED THAT THEY DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE HOME PATIENT ALSO STATED THEY ARE CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THE HOME PATIENT STATED THIS WAS AN ISOLATED EVENT.

    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 PD CYCLER