BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2060308 · Received April 15, 2011

    Report

    Report Number
    1423500-2011-04600
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 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 FOR SYSTEM ERROR SE 2267 (FLUID AND AIR IN SET) WAS NOT CONFIRMED. A ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. 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 REGARDING A SYSTEM ERROR 2267 (AIR AND FLUID IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING FILL 4 OF 5. THE HOME PATIENT (HP) STATED THAT HE WAS STILL CONNECTED TO HC MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP, ASSISTED TO CLEAR THE ALARM AND ADVISED TO CONTACT THE NURSE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP REGARDING THE ALARM, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED; HOWEVER, THE CAUSE OF THE ALARM REMAINED UNKNOWN. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, HE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT; HE HAD NOT INFORMED HIS NURSE OF THE INCIDENT. THE HP WAS ADVISED TO LET HIS NURSE OF THE ALARM. THE HP STATED THAT HE WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    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 68 YR HOMECHOICE CYCLER