BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2173471 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09336
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 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 THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DRAIN 3 WAS NOT CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) NURSE REGARDING THE REPORTED EVENT. THE NURSE STATED THAT THE HP DID NOT HAVE ANY RESIDUAL EFFECTS FROM THE SYSTEM ERROR 2240. THE NURSE STATED THAT THE HP DID CHOOSE TO SWITCH FROM PERITONEAL DIALYSIS TO HEMO DIALYSIS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DRAIN 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HOME PATIENT (HP) WITH CLEARING THE ERROR AND INFORMED THE HP THE MEANING OF THE ERROR. THE HP STATED THAT THEY DID NOT DISCONNECT AND THERE WERE NO LEAKS IN THE SETUP. ALL THE CLAMPS THAT SHOULD BE OPEN WERE OPEN. THE HP WOULD STOP THE THERAPY AND CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN). THERE WAS PATIENT INVOLVEMENT BUT NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS 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 66 YR HOMECHOICE