BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2862497 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06743
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION:THE PROBLEM WAS NOT CONFIRMED, AS NO SAMPLE WAS RETURNED FOR EVALUATION. THEREFORE, THE CAUSE COULD NOT BE DETERMINED. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF CATHETER CAME APART WHILE IN BED, PERITONITIS WITH (B)(6) AND PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA PARAPSILOSIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT'S CATHETER CAME APART (DISCONNECTED) WHILE IN BED AND WAS PUT BACK WITHOUT ANY TREATMENT, WHICH CAUSED PERITONITIS. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS FOUND TO BE POSITIVE FOR (B)(6) AND CANDIDA PARAPSILOSIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT RECOVERED FROM THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) AND PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA PARAPSILOSIS. ON (B)(6) 2012 BAXTER PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS NURSE. THE NURSE STATED THE PATIENT USED A TITANIUM ADAPTER IN CONJUNCTION WITH THEIR CATHETER. THE PATIENT HAD BEEN RETRAINED AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT'S CATHETER HAD BEEN PULLED AND THE PATIENT SWITCHED OVER TO HEMODIALYSIS THERAPY. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention DIANEAL PD4 ULTRABAG