BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240174 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11917
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 20, 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). PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING A SYSTEM ERROR 2240. THE HP REPORTED THAT THE ISSUE WAS RESOLVED, BUT THEY DID NOT KNOW THE CAUSE OF THE ALARM. PER HP, THERE WERE NO LOOSE CONNECTIONS, (UNINTENTIONAL) DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP STATED THAT THEY DID NOT DISCUSS THE ALARM WITH THEIR NURSE. PER HP, THEY DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT THEY ARE DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT THEY HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED. PRODUCT SURVEILLANCE SPOKE WITH THE REGISTERED NURSE (RN) ON (B)(6) 2011 REGARDING A SYSTEM ERROR 2240. THE RN STATED SHE WAS UNAWARE OF THE SITUATION. THE RN STATED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED FOR THE HP. THERAPY HAS BEEN GOING WELL. NO FURTHER INFORMATION WAS PROVIDED. THE REPORTED SYSTEM ERROR 2240 ALARM WAS NOT CONFIRMED. A USED SAMPLE, DISPOSABLE SET OR MACHINE WAS NOT RETURNED TO BAXTER FOR COMPLAINT INVESTIGATION. THE CAUSE IS UNDETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. 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 ALARM WITH THE HOMECHOICE (HC) MACHINE DURING USE. THE HOME PATIENT (HP) STATED HE WAS STILL CONNECTED TO THE MACHINE. THE TSR ADVISED THE HP TO CONTACT THE NURSE FOR FURTHER ASSISTANCE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 HOMECHOICE