BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2060344 · Received April 16, 2011

    Report

    Report Number
    1423500-2011-04612
    Event Type
    Injury
    Date Received
    April 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10D19067, H10F28071, H10E05030, AND H10D30064 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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. THE SPECIFIC PRODUCT CODE FOR THE (MINICAP TRANSFER SET) IS UNKNOWN. THE BRAND NAME AND 510K HAVE BEEN PROVIDED IN THIS MDR. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS NURSE REPORT FROM THE USA OF ACCIDENTALLY UNHOOKED HERSELF AND PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT ACCIDENTALLY UNHOOKED HERSELF. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. TREATMENT WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2011, THE PATIENT RECOVERED FROM THE PERITONITIS. THE OUTCOME OF THE EVENT OF THE PATIENT ACCIDENTALLY UNHOOKED HERSELF WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS UNRELATED TO DIANEAL THERAPY AND WAS DUE TO THE PATIENT UNHOOKING HERSELF. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF ACCIDENTALLY UNHOOKED HERSELF.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization DIANEAL PD4 AMBUFLEX