BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2991481 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05425
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PROBLEM COULD NOT BE CONFIRMED, AS THERE WAS NO SAMPLE FOR EVALUATION. THEREFORE THE CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS PERFORMED, AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING OF POTENTIALLY ASSOCIATED LOT GD893305. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SAME PATIENT AS (B)(4). THIS IS REPORT 2 OF 2. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95832 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization DIANEAL PD4 2.5%, DIANEAL PD4 4.25%, HOMECHOICE