BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1811773 · Received August 23, 2010

    Report

    Report Number
    1423500-2010-02792
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY NECESSARY SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR SYSTEM ERROR 2267 ALARM (AIR AND FLUID IN DISPOSABLE SET) WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. DURING THERAPY, THE NURSE SAW THE A SOLUTION BAG EMPTY, SO SHE DISCONNECTED THE HEATER BAG AND SUPPLY BAG, AND ADDED A NEW BAG TO BOTH LINES, BUT THEN RECEIVED THE SE 2267 ALARM. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE ALARMS IS USE ERROR WHEN AIR WAS SUCKED INTO THE DISPOSABLE WHEN THE NURSE DISCONNECTED THE SOLUTION BAGS DURING THERAPY. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. 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

    DURING EVALUATION OF THE THERAPY LOGS OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 3. THE PATIENT'S DRAIN VOLUME WAS 6472ML. THE LARGEST PRESCRIBED FILL VOLUME WAS 3000ML. THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE THE PATIENT HAS BEEN SEEN SINCE THIS EVENT AND HAS RESUMED THERAPY. THE PATIENT HAS NOT REPORTED ANY SYMPTOMS OF OVERFILL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2267 (AIR OR FLUID IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING USE. THE NURSE REPORTED THAT A BAG WAS EMPTY, SO SHE DISCONNECTED THE HEATER BAG AND SUPPLY BAG, AND ADDED A NEW BAG TO BOTH LINES, BUT THEN RECEIVED THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE NURSE AND WHY SHE SHOULD NOT DISCONNECT AND RECONNECT BAGS. THE TSR ASSISTED WITH TROUBLESHOOTING. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES OR FINISH WITH MANUAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE NURSE REGARDING THE ALARM, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED AND THAT THEY HAD DECIDED TO END THERAPY THAT NIGHT. PER NURSE, SHE DID NOT RECALL THE NAME OF THE PATIENT OR THE REASON THE PATIENT WAS IN THE HOSPITAL. THE NURSE STATED THAT HP WAS DOING FINE WHEN DISCHARGED. THE NURSE DID NOT PROVIDE AND FURTHER INFORMATION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1