BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2223372 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11246
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 2, 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 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS: GD884445 AND GD883496 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    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 SWOLLEN STOMACH AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX AND DIANEAL PD2 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR STOMACH SWELLING AND PERITONITIS MANIFESTED BY ABDOMINAL PAIN. TREATMENT INCLUDED UNSPECIFIED MEDICATION. ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD RECOVERED FROM THE EVENTS. ON AN UNREPORTED DATE IN 2011, THE PATIENT WAS DISCHARGED. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY AND DID NOT COMMENT ON THE SWOLLEN STOMACH.

    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 48 YR Hospitalization DIANEAL PD2 AMBUFLEX| DIANEAL PD2 ULTRABAG