BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2171758 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09292
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE 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. THE TREND IS STABLE. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). RENAL QE, ALONG WITH PLANT MANUFACTURING AND QUALITY, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR 2240 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF THE HP WAS CONNECTED WHEN MACHINE ALARMED, AND THE HP STATED YES. THE TSR INSTRUCTED THE HP TO THE CLOSE TRANSFER SET AND ALL CLAMPS AND CYCLE POWER. THE TSR INSTRUCTED THE HP TO DISCARD SUPPLIES AND START OVER WITH NEW SUPPLIES. THE TSR TRIED REVIEWING PROPER PROCEDURES, BUT THE HP WAS DISTRACTED. HP STATED THAT HE WOULD START OVER. THERE WAS PATIENT INVOLVEMENT. (B)(4) 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 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 60 YR HOMECHOICE