BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1972452 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01170
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 4 REPORTED FOR THIS INCIDENT. AS PATIENTS DISCARD SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD878223, GD879171 WITH NO DEFECTS NOTED. THE ASSIGNABLE CAUSE IS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL ON (B)(6) 2010 FOR AN UNRELATED COMPLAINT THE PATIENT TOLD BAXTER THAT THEY WENT TO THE CLINIC AND WERE TREATED WITH ANTIBIOTICS FOR PERITONITIS ABOUT A WEEK AGO. THE PATIENT REPORTED THAT HE WILL FOLLOW UP WITH HIS SURGEON SOON ABOUT ISSUES WITH HIS THERAPY. . THE HP REPORTED THAT HE WAS FEELING MUCH BETTER SINCE RECEIVING THE ANTIBIOTICS AND HAS RECOVERED. ON (B)(6) 2011 BAXTER CONTACTED THE PDRN WHO STATED THAT ON (B)(6) 2011 THE PATIENT COMPLAINED THAT HIS PD EFFLUENT LOOKED A BIT LIKE PINEAPPLE JUICE. THE PDRN CONTACTED THE PHYSICIAN AND THE PATIENT WAS STARTED ON ANCEF (UNKNOWN DOSE). THE PATIENT CONTINUED TO BE TREATED WITH ANCEF (UNKNOWN DOSE) AND COMPLETED THE COURSE OF ANTIBIOTICS ON (B)(6) 2011. THE PATIENT CONTINUES THERAPY AS ORDERED. THERE IS NO FURTHER INFORMATION AVAILABLE. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HOME CHOICE CYCLER| LOCAL (PD4) AMBUFLEX 2.5%