BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2082442 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05658
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H09G06102 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE OF THE PERITONITIS IS 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 THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE WHO STATED THAT THE HOMEPATIENT(HP) HAD BEEN HOSPITALIZED FOR PERITONITIS ON (B)(6) 2011. THE NURSE STATED THE CAUSALITY WAS 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 40 YR Hospitalization HOMECHOICE| EXTRANEAL| LOWCAL (PD4) ULTRABAG| LOWCAL (PD4) AMBUFLEX