BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1915137 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06574
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT (H10F28147), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS REPORT 1 OF 3 ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR ANOTHER COMPLAINT, THE PERITONEAL DIALYSIS NURSE (PDN) INDICATED THE HOME PATIENT (HP) HAD PERITONITIS. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ON (B)(4) 2010 FROM ONE OF THE PATIENT'S PD NURSES. THE PATIENT WAS ON PERITONEAL DIALYSIS (PD) WITH LOCAL (PD4) AMBUFLEX AT THE TIME OF THE DIAGNOSIS. THE PATIENT WAS INITIALLY DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2010 AFTER HER PD EFFLUENT WAS ANALYZED ON AN UNSPECIFIED DATE. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE PDN DID NOT KNOW IF A GRAM STAIN WAS DONE. THE RESULTS OF THE INITIAL PD EFFLUENT CULTURE SHOWED (B)(6). THE PATIENT'S WHITE BLOOD CELL (WBC) COUNT ON (B)(6) 2010 WAS 6990 (UNITS NOT PROVIDED) WITH 85% POLYMORPHS. THE PATIENT WAS GIVEN ANTIBIOTICS (CEFAZOLIN). THE PATIENT WAS NOT RESPONDING WELL TO THE ANTIBIOTIC, SO OVER THE COURSE OF A FEW DAYS, THE PATIENT'S ANTIBIOTIC WAS CHANGED TO VANCOMYCIN. ON (B)(6) 2010, THE PATIENT WENT INTO THE HOSPITAL FOR THE PERITONITIS. THE PATIENT'S SUBSEQUENT PD EFFLUENT CULTURE PERFORMED BY THE HOSPITAL SHOWED A FUNGUS. THE TYPE OF FUNGUS WAS NOT SPECIFIED BY THE PDN. THE PATIENT'S WBC COUNT ON (B)(6) 2010 WAS 5240 (UNITS NOT PROVIDED) WITH 94% POLYMORPHS. THE PATIENT'S PD CATHETER WAS REMOVED AND THE PATIENT WAS PUT ON HEMODIALYSIS. THE PDN INDICATED THE REASON FOR THE PERITONITIS COULD HAVE BEEN DUE TO TOUCH CONTAMINATION; HOWEVER, SHE COULD NOT BE SURE AS THE PATIENT DID NOT SAY ANYTHING TO HER SPECIFICALLY ABOUT A BREAK IN ASEPTIC TECHNIQUE. ADDITIONALLY, THE PDN'S OPINION IS THE FUNGAL PERITONITIS MAY BE RELATED TO THE PATIENT'S PAST HISTORY OF BEING ON LONG TERM ANTIBIOTICS FOR OSTEOMYELITIS OF A FINGER OR HAND. THERE WAS NO ALLEGATION MADE AGAINST ANY OF THE PATIENT'S BAXTER SOLUTIONS OR DISPOSABLES. THE PDN STATED SHE DID CHANGE THE PATIENT'S TRANSFER SET ON (B)(6) 2010, WHICH WAS THE "SHORT" BLUE TWIST CLAMP TYPE. NO FURTHER INFORMATION WAS PROVIDED, ONLY THAT THE PATIENT IS PRESENTLY STILL IN THE HOSPITAL AND IS SHOWING IMPROVEMENT.

    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 49 YR Hospitalization| R LOCAL (PD4) AMBUFLEX