BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3965237 · Received July 29, 2014

    Report

    Report Number
    1416980-2014-24604
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS CMPLNT-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD896597. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. IN THE MONTH PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS HOSPITALIZED FOR 2 DAYS FOR SUSPECTED PERITONITIS. ELEVEN DAYS LATER, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH FORTAZ (DOSE, ROUTE, AND FREQUENCY UNKNOWN) AND VANCOMYCIN (DOSE, ROUTE, AND FREQUENCY UNKNOWN) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441874 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE| DIANEAL PD4 2.5% AND 4.25%| HOMECHOICE AUTOMATED PD SET WITH CASSETTE