BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT EXCHANGE DEVICE

    MDR report key: 2101411 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06450
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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 FIFTH OF FIVE REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE LOT NUMBER WAS UNKNOWN AND THE SAMPLE WAS NOT AVAILABLE, A BATCH REVIEW WAS NOT PERFORMED. ROOT CAUSE WAS DETERMINED AS USER ERROR- POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF USER ERROR- POOR ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER CONTACTED THE CAREGIVER(CG) FOR THE HOME PATIENT(HP) REGARDING A REPORT OF THE HP HAVING BEEN HOSPITALIZED. THE CG STATED THAT THE HP WAS HOSPITALIZED FROM (B)(6) 2011 - (B)(6) 2011 FOR PERITONITIS. THE CG STATED THAT THE HP ACCIDENTLY TOUCH CONTAMINATED ON A PREVIOUS NIGHT. PERITONEAL DIALYSIS(PD) EFFLUENT CELL COUNTS AND CULTURES WERE OBTAINED. THE CG STATED THAT THE HP WAS ON A MEDICATION WHICH CAUSED HER TO GET LOOPY AT NIGHT, AND THE HP FORGOT TO USE HAND SANITIZER BEFORE CONNECTING. BAXTER CONTACTED THE PDRN WHO CONFIRMED THE INFORMATION AND STATED THAT THE HP HAD RECOVERED FROM THE EVENT AND CONTINUED TO RECEIVE PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT EXCHANGE DEVICE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization LOWCAL(PD4) AMBUFLEX| HOME CHOICE