BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2052978 · Received April 13, 2011

    Report

    Report Number
    1423500-2011-04432
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS GD880757, GD881474), WITH NO DEFECTS NOTED. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. 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 AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE IN THE USA OF PERITONITIS COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE RESULTING IN A TOUCH CONTAMINATION WHILE PERFORMING THERAPEUTIC PD. THE TREATMENT AND OUTCOME FOR THE TOUCH CONTAMINATION WERE NOT REPORTED. THE CONSUMER REPORTED THAT ON (B)(6) 2011, SHE EXPERIENCED PERITONITIS. THE NURSE REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS ON (B)(6) 2011. ON AN UNREPORTED DATE, PERITONEAL EFFLUENT CULTURES WERE OBTAINED AND RESULTS WERE POSITIVE FOR STREPTOCOCCUS. THE TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE IN 2011, THE PATIENT RECOVERED. PER THE NURSE, THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS WAS NOT RELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF 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 67 YR Other DIANEAL PD4 ULTRABAG