BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2013206 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02985
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS REPORT WAS DUE TO USE ERROR, POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (GD878207 GD878199), WITH NO DEFECTS NOTED DURING MANUFACTURING. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE OF PERITONITIS COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING. THE PATIENT'S NURSE REPORTED THAT THE PATIENT MADE A MISTAKE WHILE PERFORMING THERAPEUTIC PD AND EXPERIENCED A TOUCH CONTAMINATION ON AN UNREPORTED DATE. CONSUMER CLARIFIED THAT HER DRAIN BAG WAS LEAKING AND WHEN THE CONSUMER WENT TO DRAIN THE BAG, SHE FORGOT TO PUT THE CAP ON THE TRANSFER SET. THE PATIENT WAS HOSPITALIZED ON AN UNREPORTED DATE IN (B)(6) 2010. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT HAD PERITONEAL EFFLUENT CULTURES TAKEN. THE RESULTS OF THE CULTURES WERE UNKNOWN. TREATMENT DURING THE HOSPITALIZATION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED AND HAD RECOVERED FROM THE PERITONITIS. THE OUTCOME FOR THE TOUCH CONTAMINATION WAS NOT REPORTED. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. PER THE NURSE, THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY; RATHER IT WAS RELATED TO THE TOUCH CONTAMINATION. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE TOUCH CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization DIANEAL PD4 ULTRABAG