BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2200525 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10537
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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 FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DRAIN 3/4 WAS CONFIRMED; PER INVESTIGATION 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. THE HOME PATIENT (HP) SAID THEY DISCONNECTED DURING THEIR DWELL CYCLE AND POSSIBLY DID NOT CLOSE THE CLAMPS. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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. 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.

    Description of Event or Problem · 1

    DURING ASSISTANCE FOR TROUBLESHOOTING A SYSTEM ERROR (SE) 2240 AND 2367 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN 3 OF 4. THE HOME PATIENT (HP) REVEALED THAT THEY HAD DISCONNECTED AND POSSIBLY DID NOT CLOSE THE CLAMPS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH CYCLING POWER AND CONTINUING THERAPY. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THEY CONTACTED THEIR REGISTERED NURSE BEFORE THEY CALLED TECHNICAL SERVICES. THE RN DIRECTED THEM TO CALL BAXTER. THE HP STATED FOR THAT EVENING THEY JUST ENDED THERAPY FOR THE NIGHT, AND CONTINUED AS NORMAL THE NEXT EVENING. THE HP STATED THERAPY HAS BEEN GOING FINE SINCE THEN. 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 24 YR HOMECHOICE