BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1946326 · Received January 4, 2011

    Report

    Report Number
    1423500-2011-00026
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    November 29, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED BATCH REVIEWS FOR POTENTIALLY ASSOCIATED LOTS (H10I23068, H10I03029) AND THERE WERE NO DEFECTS NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS PERITONITIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4).THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION.MORE INFORMATION WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, CUSTOMER CONTACTED BAXTER REGARDING A CHECK HEATER LINE ALARM AND REPORTED THAT HE HAD CLOUDY DRAIN FLUID. ON 15DEC2010 A BAXTER REPRESENTATIVE CONTACTED THE PATIENTS PERITONEAL DIALYSIS (PD) NURSE REGARDING THE CLOUDY DRAIN FLUID AND SHE STATED THAT THE PATIENT HAD AND INFECTION AND WENT TO THE EMERGENCY DEPARTMENT ON AN UNKNOWN DATE AND WAS GIVEN ANTIBIOTICS (THE NAME AND DOSE ARE UNKNOWN). SHE STATED THAT THE OCCURRED ON (B)(6) 2010. THE PATIENT WAS CULTURED AND TESTED POSITIVE FOR PSUEDOMONAS AERUGINOSA. THEN ON (B)(6) 2010, THE PATIENT WAS RE-CULTURED AND THE RESULTS SHOWED NO GROWTH. SHE STATED THAT ON (B)(6) 2010 THE PATIENT CAME TO THE CLINIC AND REPORTED RECTAL PAIN DURING THE DRAIN CYCLE. THE PD NURSE NOTIFIED THE PHYSICIAN AND WHO HAD THE PATIENT DISCONTINUE THERAPY ON THE CYCLER. THE NURSE STATED THAT THE PATIENT IS CONTINUING THERAPY ON MANUALS FOR NOW UNTIL THEY CHECK HER CATHETER. SHE STATED THAT THE CATHETER MAY HAVE MIGRATED IN THE PERITONEUM CAUSING THE RECTAL PAIN. THERE WAS NO ALLEGATION AGAINST ANY BAXTER PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. THE FOLLOWING ARE POTENTIALLY ASSOCIATED LOTS FOR THIS PERITONITIS EVENT: CASSETTE LOT NUMBERS (H10I23068, H10I03029),

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UKNOWN

    Patients

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