BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2213522 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10782
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 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). 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR WAS CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE USE ERROR WAS NOT DETERMINED. 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 PATIENT LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DRAIN 7 OF 7. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM BUT HAD ALREADY DISCONNECTED WHEN THEY CALLED IN FOR ASSISTANCE. THE PATIENT DID NOT CAP THE PATIENT LINE UPON DISCONNECTION. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE HAD THE PATIENT END THERAPY. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011 REGARDING THE REPORTED EVENT. THE PATIENT STATED THAT THEY DID NOT DISCONNECT ANY TIME PRIOR TO THE COMPLETION OF THERAPY. THE PATIENT STATED THEY CALLED FOR ASSISTANCE AND WERE ABLE TO RESOLVE THE ALARM. THE PATIENT STATED THEY HAVE BEEN CONTINUING THERAPY ON THEIR CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 56 YR HOMECHOICE