BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2123803 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07620
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 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). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE SUPPLY BAG CAME DISCONNECTED FROM THE SUPPLY LINE, SPIKE CAME OUT OF THE SUPPLY BAG. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING DWELL 3 OF 4. THE HOME PATIENT (HP) STATED THAT THE SPIKE CAME OUT OF THE SUPPLY BAG AND SHE TRIED TO PUSH THE SPIKE BACK IN HOWEVER THE HC ALARMED WITH SE 2240. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE TSR ASSISTED THE HP TO CYCLE POWER OFF AND ON TWICE TO CLEAR ALARM AND EXPLAINED TO START OVER OR TRY USING MANUALS TONIGHT. THE HC WAS OPERATIONAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011. THE PATIENT STATED THE FOLLOWING: THE ALARM WAS CAUSED AS SHE INITIALLY COULD NOT GET THE SPIKE INTO THE BAG SECURELY AND REMOVED IT AND RE-SPIKED IT SEVERAL TIMES UNTIL IT WENT IN PROPERLY. THE CAUSE OF THE ALARM WAS DUE TO HER MISTAKE AND NOT THE SUPPLIES. THE NURSE WAS CONTACTED REGARDING THE EVENT AND NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 85 YR HOMECHOICE