BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2101406 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06448
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS GD882258, GD882241 AND GD880781 WITH NO DEFECTS NOTED DURING BATCH REVIEW THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. 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.

    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 THIRD OF FIVE REPORTS ASSOCIATED WITH THIS EVENT.

    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 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization HOMECHOICE| LOCAL(PD4)AMBUFLEX