BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2153769 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08789
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 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). 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. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WAS CAUSED BY A USE ERROR; THE PATIENT NOT MAKING TIGHT CONNECTIONS BETWEEN TRANSFER SET AND PATIENT LINE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE PATIENT LINE ON THE HOMECHOICE MACHINE THAT CAME LOOSE DURING DRAIN 2. THE SOLUTION WAS GOING ON THE FLOOR. THE DRAIN VOLUME WAS 1487ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO END THE THERAPY, AND THE TSR INFORMED THE HP TO CONTACT HIS NURSE. THE TSR INFORMED THE HP TO START OVER USING NEW SUPPLIES. THERE WAS NO ALARM ON THE MACHINE. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE NURSE ON (B)(6) 2011. THE NURSE STATED THE FOLLOWING: THE PATIENT LINE CAME OFF THE TRANSFER SET AS THE PATIENT DID NOT MAKE A TIGHT CONNECTION. THE NURSE REVIEWED THE EVENT WITH THE PATIENT, AND PROPHYLACTIC ANTIBIOTICS WERE GIVEN AS A PRECAUTION. THE PATIENT IS CURRENTLY DOING FINE WITH THERAPY AND THERE WAS NO PATIENT INJURY 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 82 YR HOME CHOICE