BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1862611 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04240
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    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). IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE AT THIS TIME.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR SEPARATION OF A SUPPLY BAG WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION THE CAUSE OF THE COMPLAINT IS THE SEPARATION OF THE SPIKE BAG WHEN THE PATIENT LIFTED THE SUPPLY BAG AND THE TUBING GOT CAUGHT - SUPPLY BAG DISCONNECTED WITHOUT FALLING. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER 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 A FOLLOW UP WITH THE HOME PATIENT (HP) REGARDING THE SPIKES FALLING OUT, THE HP EXPLAINED THAT SHE HAD PROPERLY SPIKED THE BAGS, BUT WHEN WAS TRYING TO HOOK THE BAG ON THE POLE, THE TUBING GOT STUCK ON SOMETHING AND SUBSEQUENTLY YANKED THE SPIKE OUT OF THE BAG. PER HP, IT WAS ACCIDENTAL, AND CONFIRMED THAT THERE WERE NO CONNECTION ISSUES OR DEFECTS ON SUPPLIES. THE HP STATED THAT SHE IS MORE CAREFUL WHEN HANGING THE BAGS NOW. THE HP STATED, SHE IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING INFORMATION ABOUT SETUP ON THE HOMECHOICE (HC) MACHINE DURING USE. THE HOME PATIENT (HP) REPORTED THAT WHEN SHE WAS CONNECTING THE BAGS, ONE OF THE SPIKES FELL OUT AND THAT SHE KNEW SHE NEEDED TO START OVER WITH NEW SUPPLIES, BUT DID NOT KNOW HOW TO. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP THAT IF SHE WOULD CYCLE THE POWER TO THE HC MACHINE DURING SETUP, THE HC WOULD RETURN TO THE BEGINNING. THE HP TO SETUP WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 51 YR