BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1873356 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04600
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED. THE SERIAL NUMBER WAS NOT PROVIDED, THEREFORE A REVIEW CANNOT BE CONDUCTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE THIRD OF THREE COMPLAINTS FOR THIS EVENT.

    Description of Event or Problem · 1

    DURING A CALL TO THE BAXTER TECHNICAL SERVICE CENTER FOR ASSISTANCE IN CLEARING THE PATIENT LINES, THE PATIENT REPORTED HE CURRENTLY HAD PERITONITIS. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE FACILITY NURSE PROVIDED THE FOLLOWING CLINICAL INFORMATION: THE NURES CONFIRMED THE PATIENT HAD A CONFIRMED EPISODE OF PERITONITIS ON (B)(6) 2010. THE PATIENT WAS NOT HOSPITALIZED. INTERVENTIONS INCLUDED CEFAZOLIN 1 GRAM EVERY DAY INTRAPERITONEAL (IP) (LENGTH OF THERAPY UNKNOWN) AND GENTAMYCIN 40MG IP (LENGTH OF THERAPY UNKNOWN). THE PATIENT WAS LATER CHANGED TO VANCOMYCIN 1 GRAM EVERY WEEK IP (LENGTH OF THERAPY UNKNOWN). THE PATIENT HAS RECOVERED FROM THE EVENT. THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE AND TOUCH CONTAMINATION. THE PATIENT HAS BEEN RETRAINED.

    Description of Event or Problem · 1

    THE PT EXPERIENCED A STRONG PAIN AND "STRAIN" IN THE GLUTEUS AREA 40 MINS AFTER LEAVING AN ELECTRONICS STORE. IT WAS ALSO NOTED THAT THE PT HAD A DIFFERENT PARASTHESIA SENSATION WHICH LASTED UNTIL THE NEUROSTIMULATOR WAS INTERROGATED WITH THE CLINICIAN PROGRAMMER THE NEXT DAY. SHE TRIED TO SWITCH THE DEVICE OFF WITH THE PT PROGRAMMER BUT AN ERROR MESSAGE "505" APPEARED ON THE SCREEN. WHEN THE DEVICE WAS INTERROGATED WITH THE CLINICIAN PROGRAMMER, THE DEVICE WAS PROGRAMMED AT THE POWER-ON-RESET (POR) PARAMETERS. AFTER REPROGRAMMING TO THE PREVIOUS PROGRAM SETTINGS (0- 3+, 35 HZ, 210 MICROSECOND; 0.55 VOLTS) THE PT WAS REPORTED AS OKAY. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXD II SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%?