BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2143118 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08454
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 6, 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 REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD879924 WHICH REVEALED VOIDS WERE NOTED IN THE POUCH SEAL DURING MANUFACTURING. CORRECTIVE ACTIONS WERE IMPLEMENTED BY THE MANUFACTURING FACILITY AND A RE-INSPECTION OF THE LOT WAS PERFORMED WHICH REVEALED ALL AFFECTED UNITS WERE REMOVED PRIOR TO RELEASE OF THE LOT. 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 PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES INTRAPERITONEALLY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE AND ORGANISM OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011 AND TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. AN OPINION OF CAUSALITY WAS NOT REPORTED.

    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 62 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG