BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2072215 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05152
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 6, 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
    PATIENT

    Narratives

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT GD879916 AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THAT LOT. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR - POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR(S) IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE (B)(6) OF PATIENT MADE A MISTAKE/TOUCH CONTAMINATION AND PERITONITIS IN A MALE (AGE NOT REPORTED) COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A MISTAKE AND TOUCH CONTAMINATION AND DEVELOPED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING AND IF TREATMENT WAS PROVIDED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME OF THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. A CAUSALITY STATEMENT WAS NOT PROVIDED.

    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 Other DIANEAL PD4 ULTRABAG