BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2070112 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05070
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD881565 WITH NO DEFECTS NOTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD880807 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.

    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FORM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON (B)96) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (LOT NUMBER, DOSAGE AND FREQUENCY NOT REPORTED). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS NOT HOSPITALIZED. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE, "THE PATIENT'S CATHETER MUST BE REMOVED DUE TO INFECTION AND PUT BACK IN". TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. NO OPINION OF CAUSALITY WAS 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 73 YR Other DIANEAL PD4 ULTRABAG