BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241965 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12006
    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 REPORTED SYSTEM ERROR 2240 OCCURRED WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION. 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 TO REPORT HAVING A SYSTEM ERROR 2240 AND SYSTEM ERROR 2367 ALARM WITH THE HOMECHOICE (HC) MACHINE DURING DRAIN 3 OF 6. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ADVISED THE HOME PATIENT (HP) TO CYCLE POWER TWICE TO CLEAR THE ALARMS. THE TSR THEN EXPLAINED THAT THE SUPPLIES WERE COMPROMISED. THE TSR WAS UNABLE TO FIND THE CAUSE SO THE HP WOULD SAVE THE CASSETTE. THE HP WOULD FINISH WITH MANUAL SUPPLIES. THE TSR ADVISED THE HP TO CONTACT THE NURSE TO ADVISE HER OF THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE REPORTED EVENT. THE HP STATED HE DID NOT KNOW WHAT MAY HAVE CAUSED THE ALARM TO OCCUR. THE HP PROVIDED THE LOT NUMBER. THE HP ADVISED THAT HE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THE HP STATED HE RECEIVED A NEW CYCLER TO RESOLVE THE ISSUE. THE HP STATED HE HAS NOT HAD ANY ISSUES SINCE RECEIVING THE NEW CYCLER. THE HP DID CONTACT HIS NURSE WHO ADVISED HIM ON PROPER PROCEDURES. THERE WAS NO PATIENT 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 H11E27025

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR HOMECHOICE