BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241821 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11986
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 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). THE COMPLAINT IS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE HOME PATIENT. THE ROOT CAUSE IS ANIMAL DAMAGE (USE ERROR). THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER IN REGARDS TO HAVING A LOW DRAIN VOLUME ALARM DURING DRAIN 5 OF 5. THE HOME PATIENT (HP) REPORTED HAVING A HOLE IN THE PATIENT LINE AND HAS DISCONNECTED. THE HP BELIEVES THAT HER PUPPY CHEWED THROUGH THE LINE AND THE HP WANTS TO END THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY EARLY. THE HP WOULD CALL HER NURSE REGARDING ANY MISSED THERAPY AND BEING CONNECTED WHEN THERE WAS A HOLE IN THE PATIENT LINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE RECEIVED A RETURN CALL FROM THE HOME PATIENT'S (HP) NURSE, BETH, ON (B)(4) 2011 REGARDING THE REPORTED ISSUE. THE HP'S NURSE STATED THAT SHE JUST TOOK OVER THIS HP ON (B)(6) 2011; HOWEVER, DOES NOT HAVE ANY REPORTS OF THE PATIENT HAVING HAD ANY INJURY OR MEDICAL INTERVENTION. THE HP'S NURSE STATED THAT THE HP HAS BEEN DOING FINE AND HAS BEEN CONTINUING THERAPY FINE.

    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 40 YR HOMECHOICE