BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1896822 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05596
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10E09032 AND H10G13022), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A PERITONEAL DIALYSIS NURSE'S CALL FOR AN UNRELATED SWAP REQUEST , THE PATIENT'S NURSE INDICATED THE PATIENT HAD AN INFECTION. FOLLOW-UP INFORMATION OBTAINED ON (B)(6) 2010 FROM THE PATIENT'S NURSE CONFIRMED THE INFECTION WAS PERITONITIS. THE PATIENT STARTED ON AUTOMATED PERITONEAL DIALYSIS (APD) WITH LOCAL (PD4) AMBUFLEX IN 2009. THE NURSE INDICATED THAT THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2010 BUT WAS NOT HOSPITALIZED. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THIS PERITONITIS EPISODE. THE PATIENT'S PD EFFLUENT WAS ANALYZED ON (B)(6) 2010. THE CELL COUNT SHOWED 2860 WHITE BLOOD CELLS (LEUKOCYTES), THE GRAM STAIN SHOWED MANY WHITE BLOOD CELLS WITH A FEW (B)(6) IN PAIRS, AND THE CULTURE SHOWED (B)(6). THE NURSE INDICATED THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE PERITONITIS WAS ONGOING AND IMPROVED. THE NURSE STATED THE CAUSE OF THE PERITONITIS WAS LIKELY TO BE DUE TO TOUCH CONTAMINATION AND THE PATIENT WAS RETRAINED ON ASEPTIC PROCEDURE. THERE WAS NO ALLEGATION MADE AGAINST ANY OF THE PATIENT'S BAXTER SOLUTIONS OR DISPOSABLES. THE NURSE ALSO INDICATED THE PATIENT WAS DIAGNOSED WITH A SEPARATE FUNGAL PERITONITIS EPISODE ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. NO KNOWN CAUSE OR DEVICE ISSUE WAS REPORTED. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH IS DEVICE RELATED.

    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 65 YR Required Intervention LOCAL (PD4) AMBUFLEX