BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2212663 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10744
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 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. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, FILL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MESSAGE TO THE HOME PATIENT (HP) AND INFORMED HIM TO RECYCLE THE MACHINE. THE TSR INFORMED THE HP TO USE MANUAL BAGS. NO REASON FOR THE ERROR WAS FOUND. 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 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 46 YR HOMECHOICE