BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2150359 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08697
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 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 POTENTIALLY ASSOCIATED LOT NUMBERS GD884460 AND GD883512 WITH NO EXCEPTIONS OR ISSUES OBSERVED RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. 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 FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. TREATMENT WAS NOT REPORTED. THE CONSUMER REPORTED THAT THE CAUSE OF THE PERITONITIS MAY BE DUE TO THE DENTAL WORK PATIENT HAD ON (B)(6) 2011 AND DID NOT TAKE ANY ANTIBIOTICS FOR THE DENTAL WORK. THE PATIENT WAS RECOVERING. IT WAS NOT KNOWN IF PD THERAPY WAS ONGOING. THE CONSUMER DID NOT PROVIDE AN OPINION OF CAUSALITY. THE NURSE DECLINED TO PROVIDE INFORMATION.

    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 18 YR Other HOMECHOICE| DIANEAL PD2 AMBUFLEX