BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141122 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08383
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE HP WAS KEEPING THE CLAMP ON THE PATIENT LINE CLOSED DURING PRIMING. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. AN INDIVIDUAL TREND REVUE WAS NOT PERFORMED. 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    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 HOME PATIENT (HP) STATED THAT SHE HAD THE ALARM LAST NIGHT AND ENDED TREATMENT TO GET TO WORK. THE HP WAS CALLING TO GET HELP ON THE ALARM. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED CAUSES OF THE ALARM AND FOUND HOME PATIENT (HP) WAS LEAVING THE PATIENT LINE CLAMPED CLOSED DURING PRIME. THE TSR ADVISED HP TO OPEN PATIENT LINE DURING PRIMING. TSR ALSO REFERRED THE HP TO THE SECTION AND PAGE NUMBER OF THE AT-HOME GUIDE FOR REFERENCE. TSR ADVISED HP TO CALL BACK IN IF SHE HAS ANY PROBLEMS WITH SETUP OR TREATMENT TONIGHT. PRODUCT SURVEILLANCE SPOKE WITH THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED BY STARTING OVER WITH NEW SUPPLIES. THE CAUSE OF THE ALARM WAS RELATED TO THE HOME PATIENT LEAVING A LINE CLAMPED CLOSED DURING PRIME. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT SHE 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 53 YR HOMECHOICE