BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2250844 · Received September 16, 2011

    Report

    Report Number
    1423500-2011-12308
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR LOT NUMBER H08I16033 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF USE ERROR WAS DETERMINED TO BE INTENTIONAL MISUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THIS IS AN INTERNATIONAL CODE FOR DISTRIBUTION OUTSIDE OF THE U.S., BUT IS BEING REPORTED AS IT IS THE SAME AS OR SIMILAR TO A CODE DISTRIBUTED WITHIN THE U.S. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE

    Description of Event or Problem · 1

    THIS IS AN EVENT REPORT OF PERITONITIS AT AN UNSPECIFIED DATE, FOLLOWING THE APPLICATION OF A NON-COMPLIANT TECHNIQUE REPORTED BY A HEALTH CARE PROFESSIONAL FOR A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. IT WAS REPORTED THE PATIENT HAS SUFFERED FROM SEVERAL EPISODES OF PERITONITIS AT NON SPECIFIED DATES. THIS IS ONE OF SEVERAL REPORTS FROM THIS REPORTER. THE PATIENT IS KNOWN FOR APPLYING A NON-COMPLIANT TECHNIQUE BY SCREWING THE MINICAP TRANSFER SET APART AND RINSING IT WITH TAP WATER, ALTHOUGH TOLD NOT TO DO SO. THE PATIENT WAS RETRAINED REPEATEDLY BY THE CENTER. THE HEALTHCARE PROFESSIONAL SUSPECTED A CAUSAL RELATIONSHIP BETWEEN THE REPEATED PERITONITIS EPISODES AND THE UNSTERILE TECHNIQUE APPLIED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H08I16033

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other