BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2150363 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08700
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR LOT NUMBER GD882613 WITH NO EXCEPTIONS OR ISSUES OBSERVED RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF A PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION THAT RESULTED IN PERITONITIS ON AN UNKNOWN DATE. THE PATIENT WAS HOSPITALIZED (B)(6) 2011. TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED (B)(6) 2011. THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. THE OUTCOME OF THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN. THE NURSE BELIEVED THE EVENT OF PERITONITIS WAS CAUSED BY THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND WAS NOT RELATED TO DIANEAL 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 31 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX