BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3973147 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25029
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD896845, GD896936 AND GD896597 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING AND THE PATIENT WAS RECOVERING. ON THE SAME DAY AS ONSET, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH VANCOMYCIN (1 GRAM, FREQUENCY NOT REPORTED) IP-INTRAPERITONEALLY AND FORTAZ (1 GRAM, ONCE) ROUTE NOT REPORTED. ON THE SAME DAY, TREATMENT WITH FORTAZ WAS DISCONTINUED. ON AN UNREPORTED DATE, VANCOMYCIN DOSAGE WAS CHANGED TO (750 MG, FOR 10 DOSES) IP. DIANEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVED AND THE PATIENT WAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450201 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention HOMECHOICE| DIANEAL PD4, 2.5% AMBUFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE