BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1810268 · Received August 20, 2010

    Report

    Report Number
    1423500-2010-02756
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. NO FURTHER INFORMATION IS AVAILABLE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS FOR THE CASSETTE (H10D30015, H10E16029) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED BAXTER AND DURING THE CALL MENTIONED THAT THE PATIENT HAD PERITONITIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP CALL FOR AN UNRELATED COMPLAINT, ON (B)(6)2010, THE HOME PATIENT REPORTED THAT HE HAD PERITONITIS. THE PATIENT INDICATED THAT THE PIECE THAT CONNECTS TO THE END OF HIS CATHETER FELL OFF ON A SUNDAY AND WAS REPLACED BY MONDAY. PER THE PATIENT, THAT WAS THE FIRST WEEK OF (B)(6) AND THAT WAS THE CAUSE OF THE PERITONITIS. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ON 10/04/2010: THE PATIENT STARTED ON AUTOMATED PERITONEAL DIALYSIS (APD) WITH LOCAL (PD4) AMBUFLEX ON (B)(6)2010. ON (B)(6)2010 THE PATIENT'S TRANSFER SET FELL OFF AND ON (B)(6)2010, THE PATIENT PRESENTED WITH CLOUDY EFFLUENT AND ABDOMINAL PAIN AND WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. A CELL COUNT, GRAM STAIN, AND CULTURE WERE PERFORMED ON THE PATIENT?S PD EFFLUENT. THE CELL COUNT AND GRAM STAIN RESULTS WERE UNKNOWN. THE CULTURE SHOWED GRAM POSITIVE (B)(6). THE PATIENT WAS GIVEN VANCOMYCIN 2 GRAMS (GM) INTRAPERITONEAL (IP) AND GENTAMYCIN 80 MILLIGRAMS (MG) IP. ONCE THE CULTURE RESULTS RETURNED, THE PATIENT WAS TAKEN OFF THE GENTAMYCIN AND CONTINUED ON THE VANCOMYCIN. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS WAS THE TRANSFER SET SEPARATION. THE NURSE ALSO INDICATED THAT THE TRANSFER SET HAD BEEN IN USE SINCE (B)(6) 2010. THE PATIENT WAS USING A TITANIUM CATHETER ADAPTER WITH THE TRANSFER SET, AND THERE WAS NO VISIBLE DAMAGE OR RESIDUE ON THE CATHETER ADAPTER THREADS. THERE WAS NO ASSIST DEVICE USED TO MAKE THE TRANSFER SET CONNECTION, AND THERE WERE NO CONNECTION OR DISCONNECTION DIFFICULTIES NOTED. THE TRANSFER SET LOT NUMBER IS UNKNOWN AND THE TRANSFER SET IS NOT AVAILABLE FOR EVALUATION. THE NURSE INDICATED THE PATIENT HAS RECOVERED FROM THE PERITONITIS AND HAS BEEN ABLE TO CONTINUE WITH PD THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG FKX FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention