BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1771107 · Received July 27, 2010

    Report

    Report Number
    1423500-2010-01660
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 23, 2010
    Report Date
    May 23, 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 (AIR IN SET) OCCURRED DURING DWELL 3 OF 3 COULD NOT BE CONFIRMED IN THE LAB. THE SET WAS INSPECTED IN THE LAB VISUALLY AND PLACED ON A MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED; THEREFORE, THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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 HAS BEEN RECEIVED BY BAXTER AND THE EVALUATION IS IN PROCESS. UPON COMPLETION OF THE EVALUATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. THROMBUS WAS PRESENT IN THE PROXIMAL NECK AT AORTA AND THE ENTIRE WALL OF THE COMMON ILIAC ARTERIES. ON (B)(6) 2010, THIS PT REPORTED A FEELING OF ABDOMINAL DISTENSION AND PAIN. COMPUTED TOMOGRAPHY WAS PERFORMED, BUT THE PT SUFFERED RESPIRATORY ARREST DURING THE PROCEDURE. AN EMERGENCY SURGERY WAS PERFORMED FOR AN INTESTINAL RESECTION. HOWEVER, THE PT HAD CARDIAC ARREST AND EXPIRED DURING LAPAROTOMY. AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS EXTENSIVE PERIPHERAL VASCULAR EMBOLIZATION WHICH OCCURRED DURING THE INITIAL PROCEDURE AND BOWEL NECROSIS. THE PHYSICIAN BELIEVES THAT BOWEL NECROSIS MAY HAVE BEEN CAUSED BY INJECTING THE CONTRAST AGENT IN A RETROGRADE FASHION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM (INDICATING AIR IN THE SET) THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DWELL 3 OF 3. THE HOME PATIENT (HP) STATED THAT HE WAS CLOSE TO BEING FINISHED WITH THERAPY, SO HE WOULD JUST END IT. THE CAUSE OF THE ALARM WAS UNKNOWN. THE HP WAS ADVISED TO CALL THE NURSE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE HP, WHOM AGREED TO SEND THE SAMPLE BACK FOR EVALUATION. THE HP STATED THAT HE HAS BEEN FINE AND ABLE TO CONTINUE THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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 75 YR