BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1820796 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03017
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    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 WAS NOT CONFIRMED AND A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO A LOOSE CONNECTION BETWEEN A SUPPLY LINE AND A SOLUTION BAG. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV100 DEVICE WAS OBSERVED LEAKING AT AN UNKNOWN LOCATION OF THE DEVICE BEFORE USE. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 250ML OF PAMIDRONATE (CONCENTRATION 90 MG IN 250 ML OF 0.9% SODIUM CHLORIDE). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT A SYSTEM ERROR 2240 (INDICATING AIR IN THE SET) ON THE HOMECHOICE MACHINE DURING DWELL 2 OF 3. THE HOME PATIENT (HP) WAS STILL CONNECTED AND THE SUPPLY BAGS WERE EMPTY. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE ASKED IF ANY BAG HAD COME UNDONE AND THE HP SAID NO, BUT THERE WAS AIR AND SOLUTION IN THE SUPPLY BAG. THE HP HAD A LOOSE BAG SPIKE WHICH WAS NOT COMPLETELY INSERTED INTO THE BAG. THIS WAS MOST LIKELY CAUSING SOME SOLUTION TO LEAK OUT, BUT THAT BAG WAS STILL CONNECTED AND THE HP COULD NOT CONFIRM THAT WAS ABSOLUTELY WHERE THE FLUID ORIGINATED FROM. THE HP WOULD FINISH THERAPY WITH A MANUAL BAG. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. UPON FOLLOW-UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE ON (B)(6) 2010, IT WAS FOUND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THE INCIDENT. THE PATIENT HAS CONTINUED THERAPY ON THE CYCLER WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR