BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2111636 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06987
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 13, 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). THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED BY GLOBAL PHARMACOVIGILANCE. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) IP FOR PD. THE NURSE CONFIRMED THAT ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS THAT RESULTED IN HOSPITALIZATION ON THE SAME DAY. THE NURSE STATED THAT THE PERITONEAL EFFLUENT CULTURE REVEALED NEISSERIA, THOUGH IT HAD NOT BEEN OFFICIALLY CONFIRMED. THE PATIENT STATED THAT HE WAS NOT ILL RECENTLY OR COUGHING PRIOR TO PD THERAPY. THE PATIENT ALSO STATED THAT HE WORE A MASK WHEN HE DID PD THERAPY. THE NURSE STATED THAT THE PATIENT WAS FINISHING HIS UNSPECIFIED ANTIBIOTIC TREATMENT AND HIS CURRENT PERITONEAL EFFLUENT CULTURE WAS CLEAR. THE NURSE STATED THAT AROUND (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. DIANEAL PD2 AMBUFLEX AND DIANEAL PD2 ULTRABAG THERAPIES WERE ONGOING. MEDICAL HISTORY INCLUDED DIABETES MELLITUS. THE NURSE STATED THAT THE BACTERIAL PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE NURSE REPORTED THAT THE BACTERIAL PERITONITIS MAY HAVE BEEN DUE TO COUGHING.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT. 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 WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER (GD881557). THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. 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. 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 (B)(6). THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT STATED THAT ON (B)(6) 2011, HE EXPERIENCED PERITONITIS THAT RESULTED IN HOSPITALIZATION ON THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT PROVIDED FOR THE EVENT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. EVENT OUTCOME WAS UNKNOWN. ACTION TAKEN WITH DIANEAL PD2 AMBUFLEX THERAPY WAS NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT PROVIDED.

    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 51 YR Hospitalization HOMECHOICE DEVICE| DIANEAL PD2 AMBUFLEX