BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXD II

    MDR report key: 1801983 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02559
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) ON (B)(6) 2010, WHO STATED HE GOT INTO A HURRY WHEN SPIKING WITH THE COMPACT EXCHANGE DEVICE (CXD) AND THAT IS WHEN THE PROBLEM OCCURRED. SINCE THAT TIME, THE HP STATED THAT HE HAS BEEN FOLLOWING THE STEPS AND SLOWLY SPIKING USING THE CXD AND ALL HAS BEEN GOING WELL. THE HP STATED THAT HE IS STILL ON PD THERAPY USING THE HOMECHOICE AND DENIED ANY INJURIES OR ILLNESS. NO SAMPLE WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE DURING SETUP. THE HOME PATIENT (HP) NEEDED ASSISTANCE WITH THE COMPACT EXCHANGE DEVICE (CXD), BECAUSE THE HP STATED THE SPIKE BROKE OFF WHEN HE TRIED TO CONNECT THE BAG. THE HP WAS NOT SURE HOW IT HAPPENED, BUT HE DIDN'T SEE THE SPIKE ON THE END OF THE LINE. THE HP SEEMED VERY CONFUSED ABOUT SETTING UP THE SUPPLIES. GTS ASSISTED THE HP TO RESTART WITH NEW SUPPLIES. THE HP WOULD CONTINUE WITH SETUP AND CALL BACK WITH ANY QUESTIONS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A KINK WAS FOUND IN THE DISTAL END OF THE SHEATH. THE GUIDE WIRE WAS DIFFICULT TO ADVANCE INTO THE PROGLIDE AND AFTER CONTINUALLY TRYING TO ADVANCE THE GUIDE WIRE, THE GUIDE WIRE PUNCTURING A HOLE THROUGH THE SHEATH CREATING ITS OWN LUMEN. THE TIP OF THE PROGLIDE FOLDED BACK INTO THE PATIENT'S ILIAC, POSSIBLY BECAUSE OF STENOSIS. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION FOR APPROXIMATELY 15 MINUTES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL 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 80 YR