BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2033009 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03820
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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 WAS FOR A CHECK DRAIN LINE ALARM THAT WAS NOT RESOLVED VIA STANDARD TROUBLESHOOTING PRACTICES. THE DISPOSABLE SET WAS NOT RETURNED FOR EVALUATION. THE HOME PATIENT NOTED THE DRAIN LINE WAS SUBMERGED IN FLUID IN THE DRAIN RECEPTACLE; IT IS UNKNOWN WHETHER THIS CONTRIBUTED TO THE REPORTED ALARM. CURRENT LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE REPORTED USE ERROR. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK DRAIN LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DRAIN 2. THE HP STATES LINE IS SUBMERGED IN A CONTAINER AND REFUSED TO REMOVE THE EXTENSION TO CHECK THE LINE. THE TECHNICAL SERVICE REPRESENTATIVE HAD THE HP END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) STATED THEY WERE AWARE OF THE PROBLEM. THE PD RN STATED THAT THE HP IS FINE AND DOING OKAY WITH HER THERAPY. THE PD RN STATED THAT SHE REVIEWED THE THERAPY PROCEDURE WITH THE HP. THERE WAS NO 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 50 YR HOMECHOICE