BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2232881 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11626
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 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 REPORT IS CONFIRMED DUE TO THE USE ERROR DESCRIBED BY THE HOME PATIENT, WHO STATED THERE WAS AIR IN THE PATIENT LINE, WHICH IS THE CAUSE OF THE ALARM. A LABELING REVIEW WAS PERFORMED AND WAS FOUND TO BE ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. THIS ISSUE IS BEING INVESTIGATED UNDER A CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4).THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER. THEREFORE THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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 TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM DURING DRAIN 1 OF 6 ON THE HOMECHOICE MACHINE(HC). THE HP STATED THERE WERE AIR BUBBLES IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HP WAS CONTACTED ON (B)(6) 2011. THE HP STATED SHE DID NOT DEVELOP ANY ADVERSE REACTIONS OR NEED ANY MEDICAL INTERVENTION. THE HP STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES WERE FOUND. THERE WAS PATIENT INVOLVEMENT; HOWEVER, 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 51 YR HOMECHOICE