BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180307 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09761
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 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 DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. LABEL REVIEW WAS NOT PERFORMED NO USER ERROR WAS SUSPECTED. COMPLAINTS TREND WAS ASSESSED IN COMPLAINT TREND INVESTIGATION (B)(4) AND IS SHOWN BE STABLE. BAXTER WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) AND THE BAGS WERE CONNECTED. THE HP HAD ALREADY CYCLED POWER OFF AND ON AND GOT SYSTEM ERROR 2367. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLED POWER OFF AND ON AGAIN. THE ALARM CLEARED. THE TSR ADVISED HP TO LET REGISTERED NURSE (RN) KNOW OF AIR DETECT ALARM. THE HP WOULD DO MANUAL DRAIN TO COMPLETE THERAPY. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED, HOWEVER, THE CAUSE OF THE ALARM REMAINED UNKNOWN. THE HP ENDED THERAPY AND MANUALLY DRAINED TO COMPLETE THERAPY. 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. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT HE 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 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 37 YR HOMECHOICE