BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2173091 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09325
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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 SAMPLE WAS DISCARDED BY THE CUSTOMER. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. 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 REPORT OF A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES(GTS) REGARDING ASSISTANCE WITH A CHECK PATIENT LINE ALARM DURING DRAIN 3 OF 4 ON THE HOMECHOICE MACHINE(HC). THE HOME PATIENT STATED THERE WAS AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE HOME PATIENT(HP) TO END THERAPY. THE TSR ADVISED THE HP TO CONTACT THEIR NURSE. THE HP WAS CONTACTED ON (B)(6) 2011. THE HP STATED HE WAS NOT SURE HOW AIR GOT IN TO THE PATIENT LINE. THE HP STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES WERE FOUND. THE HP STATED THAT HE DID NOT HAVE ANY ADVERSE REACTIONS OR NEED ANY MEDICAL INTERVENTION. 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 57 YR HOMECHOICE PRO