BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3013318 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06733
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE DISPOSABLE CASSETTE WAS NOT RETURNED AND THE DEVICE'S LOT NUMBER WAS UNAVAILABLE, A DEVICE ANALYSIS AND BATCH REVIEW CANNOT BE COMPLETED. HOWEVER, IT WAS REPORTED THAT THE HP CONNECTED THE PATIENT EXTENSION LINE AFTER PRIMING. THIS EVENT IS KNOWN TO CAUSE A 2240 ALARM. PER BAXTER LABELING, THE PATIENT IS INSTRUCTED TO CONNECT ANY PATIENT LINE EXTENSIONS PRIOR TO PRIMING THE HOMECHOICE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED 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 SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING PERITONEAL DIALYSIS, DWELL 1 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) POWER CYCLE THE HC AND A SYSTEM ERROR 2367 OCCURRED. THE HP THEN ENDED THERAPY. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED PRIOR. ALL OF THE BAGS WERE PROPERLY CONNECTED AND THERE WERE NO OPEN CLAMPS ON UNUSED LINES. THERE WAS NOTHING UNUSUAL ABOUT THE SUPPLIES AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING; HOWEVER, THE HP HAD CONNECTED THE PATIENT EXTENSION LINE AFTER PRIMING. THE TSR EXPLAINED THAT THE EXTENSION LINE SHOULD BE CONNECTED PRIOR TO PRIMING. THE TSR EXPLAINED THAT THERE WAS A POSSIBLE INTODUCTION OF AIR INTO THE LINES AND THE HP NEEDED TO START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE HP TO CONTACT HER REGISTERED NURSE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116687 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE