BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2183032 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09928
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOT NUMBER H10K05047 REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOT NUMBER H11C31030 REVEALED AN EXCEPTION WAS NOTED FOR MOLDING COMPONENT ASSOCIATED WITH THE LUER CONNECTOR COMPONENT. THERE IS NO EVIDENCE TO SUPPORT ASSOCIATION TO THE REPORTED PROBLEM. THE AFFECTED PRODUCT WAS 100% INSPECTED. CORRECTIVE ACTIONS IMPLEMENTED AND EFFECTIVE. QUALITY INSPECTIONS WERE ACCEPTABLE WITH ALL PRODUCT RELEASE REQUIREMENTS ACCEPTABLE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. 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 EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE FOURTH OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) ON (B)(6) 2011 REGARDING A HOME PATIENT (HP) REPORT OF PERITONITIS. THE PDRN STATED THAT THE HP, ON A DATE PREVIOUS TO (B)(6) 2011, EXPERIENCED SYMPTOMS AND WENT TO THE HOSPITAL EMERGENCY ROOM ONLY FOR A PERITONEAL DIALYSIS (PD) EFFLUENT ANALYSIS. THE PDRN STATED THAT THE HP WAS TREATED, BUT THAT SHE COULD NOT DISCLOSE FURTHER INFORMATION OTHER THAN THE CAUSALITY WAS THE HP NOT WEARING HIS MASK DURING CONNECTION AND SET UP OF PD THERAPY.

    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 70 YR Required Intervention LOCAL(PD4)AMBUFLEX| HOME CHOICE