BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXD II

    MDR report key: 1850482 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-03979
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPACT EXCHANGE DEVICE (CXD) WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER IS UNKNOWN. DURING A FOLLOW UP CALL, THE HOME PATIENT (HP) STATED THAT IT WAS HIS FAULT BECAUSE HE ACCIDENTLY PULLED THE CXD LEVER BACK AFTER SPIKING THE BAG WHICH SUBSEQUENTLY PULLED THE SPIKE BACK OUT OF THE BAG. ALTHOUGH THE DEVICE WAS NOT EVALUATED, THE INFORMATION REPORTED BY THE HP IS NOT CONSISTENT WITH A POTENTIAL MALFUNCTION. THE CAUSE FOR THE REPORTED ISSUE OF SPIKE COMING OUT WAS DETERMINED TO BE A USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HC DEVICE WAS NOT RETURNED TO BAXTER, THEREFORE AN EVALUATION WILL NOT BE PERFORMED.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE SPIKE CAME OUT OF THE HEATER BAG WHEN USING A COMPACT EXCHANGE DEVICE (CXD). THE HOME PATIENT (HP) HAD TO START OVER, BUT WAS WONDERING IF HE COULD SPIKE THE BAGS MANUALLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THAT HP COULD SPIKE BAGS MANUALLY AS LONG AS HE USED STERILE TECHNIQUE. THE HP WOULD START OVER WITH NEW SUPPLIES. THE DEVICE WAS OPERATIONAL. DURING A FOLLOW UP WITH THE HP REGARDING THE SPIKE COMING OFF THE BAG, THE HP STATED THAT IT WAS HIS FAULT AS HE HAD ACCIDENTLY (INTENTIONALLY) PULLED THE CXD LEVER BACK AFTER SPIKING THE BAG, AND THAT SUBSEQUENTLY PULLED THE SPIKE BACK OUT OF THE BAG. THE HP STATED THAT THERE WERE NO ISSUES WITH THE CXD OR ANY OF THE SUPPLIES. PER HP, HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP DID NOT KNOW THE LOT NUMBER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXD II SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR