BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1813325 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02837
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S PERITONEAL DIALYSIS CLINIC (PD) WAS CONTACTED ON (B)(6) 2010 AND BAXTER PRODUCT SURVEILLANCE WAS INFORMED BY A PD NURSE THAT A PERITONITIS EVENT REPORTED BY THE PATIENT ON (B)(6) 2010 IS A RECURRENT EVENT FROM THE ORIGINAL REPORT OF PERITONITIS. THE NURSE INDICATED THAT THE PATIENT HAS HAD THE SAME PERITONITIS STARTING IN (B)(6). THE NURSE INDICATED THAT THIS IS JUST A PERSISTENT PERITONITIS AND IS BEING TREATED ACCORDINGLY. THE NURSE INDICATED THE PATIENT HAS ALSO BEEN RETRAINED ON ASEPTIC TECHNIQUE. THE PATIENT HAS REMAINED ON PD THERAPY AND HAS BEEN ABLE TO CONTINUE WITH PD THERAPY OKAY. THE NURSE INDICATED THAT THE PATIENT WAS BEING TREATED WITH VANCOMYCIN AND THAT ON (B)(6) 2010, THE PATIENT WAS GIVEN A LAST DOSE OF 2GM, INTRAPERITONEAL.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4)AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED. THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DISCREPANT DIGOXIN (DIGN) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR ONE PATIENT. THE INITIAL RESULT OF 0.9 NG/ML WAS REPORTED OUT OF THE LABORATORY. WHEN QC WAS ERRATIC, A TECHNICIAN RERAN THE SAMPLE 3 TIMES, AND OBTAINED RESULTS OF 2.1, 1.2, AND 1.9 NG/ML. A SUBSEQUENT TESTING AT ANOTHER LAB PRODUCED RESULT OF 1.0 NG/ML. NO RESULT WAS AMENDED. THERE WAS NO EFFECT TO THE PATIENT OR THE USER.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IT WAS UNKNOWN WHETHER THERE WAS A BREAK IN ASEPTIC TECHNIQUE. TREATMENT INFORMATION WAS NOT PROVIDED. PD THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THE EVENT. ON (B)(6)2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT DISTAL CATHETER WAS BROKEN AT THE VALVE OUTLET CONNECTOR, AND THE CATHETER DETACHED FROM THE VALVE CAUSING IT TO SLIP INTO THE ABDOMEN. AS A RESULT THE DISTAL CATHETER WAS REPLACED.

    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 74 YR Hospitalization| R DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX