BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6464842 · Received April 6, 2017

    Report

    Report Number
    1416980-2017-03061
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    March 10, 2017
    Report Date
    May 26, 2017
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS IS A RESUBMISSION OF THE ORIGINAL FOLLOW-UP REPORT THAT HAD BEEN PREVIOUSLY SUBMITTED ON 05/26/2017 WITH A REPORT # OF 1416980-2017-03061-2. THE G8: MFR REPORT # IN THIS REPORT IS BEING UPDATED TO ALIGN WITH THE SEQUENCING OF G8: MFR REPORT # IN THE INITIAL MDR. THE H6 CODES IN THIS SUBMISSION HAVE BEEN UPDATED TO ALIGN WITH THE CURRENT ACCEPTED H6 CODING. ADDITIONAL INFORMATION ADDED TO H6. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN UNKNOWN BAXTER TRANSFER SET. THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE EVENT WAS REPORTED AS DUE TO THE PATIENT'S TRANSFER SET FALLING OFF. THE CAUSE OF THE DISCONNECTION WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTICS INTRAVENOUSLY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SEVEN DAYS AFTER THE ONSET. ANTIBIOTIC TREATMENT WAS COMPLETED 14 DAYS AFTER THE ONSET. AT THE TIME OF THE REPORT, THE PATIENT WAS RECOVERED. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246735 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| R DIANEAL PD4 1.5%| DIANEAL PD4 2.5%| DIANEAL PD4 4.25%| EXTRANEAL PD2| HOMECHOICE| NON-BAXTER TITANIUM ADAPTER| DIANEAL PD4 1.5%| DIANEAL PD4 2.5%| DIANEAL PD4 4.25%| EXTRANEAL PD2| HOMECHOICE| NON-BAXTER TITANIUM ADAPTER