BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2191188 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10264
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 18, 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 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS GD885293 AND GD884452 WITH NO DEFECTS NOTED. 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 CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF DIARRHEA AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED DIARRHEA. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS ON (B)(6) 2011. THE CONSUMER STATED THAT THE CAUSE OF THE PERITONITIS WAS POSSIBLE CONTAMINATION FROM THE HOSPITAL. THE NURSE REPORTED THAT THE CAUSE OF THE PERITONITIS WAS UNKNOWN, BUT THE PATIENT WAS HAVING A LOT OF DIARRHEA. TREATMENT RENDERED FOR THE EVENTS WAS NOT REPORTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. HE WAS RECOVERING FROM THE PERITONITIS. DIANEAL PD4 AMBUFLEX THERAPY WAS ONGOING. THE OUTCOME FOR THE EVENT OF DIARRHEA WAS NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL PD4 AMBUFLEX THERAPY AND DID NOT COMMENT ON THE DIARRHEA.

    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 68 YR Hospitalization DIANEAL PD4 AMBUFLEX