BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2062708 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04692
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 3, 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 SAMPLE NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THIS COMPLAINT WAS FOR A SE 2267 ALARM (AIR AND FLUID IN SET) OCCURRED DURING FILL CYCLE 7/9 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE MOST LIKELY CAUSE OF THE SE 2267 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE HP HAD FORGOTTEN TO ATTACH A BAG TO AN OPEN LINE. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK SUPPLY LINE AND REFILLING HEATER WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING FILL 7 OF 9. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) CONFIRMED THAT THE BLUE CLAMP LINE STILL HAD SOLUTION. THE TSR ASSISTED BYPASS TO FILL 7 OF 9. THE HC ALARMED SE 2267. THE TSR EXPLAINED THE ALARM TO THE REGISTERED NURSE (RN). THE TSR ADVISED TO START OVER WITH NEW SUPPLIES. THE RN WILL CALL AND CHECK WITH DIALYSIS ON HOW TO FINISH THERAPY. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE NURSE WAS CONTACTED ON (B)(6) 2011. THE NURSE STATED THAT THE HOME PATIENT DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THE HOME PATIENT IS CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THE NURSE ALSO STATED THAT THE CAUSE OF THE ALARMS WAS BECAUSE THEY HAD FORGOTTEN TO ATTACH A BAG TO AN OPEN LINE.

    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 89 YR HOMECHOICE