BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1980066 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01560
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10J19024, H10K14064, AND H10L10029), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 4 FOR THIS EVENT.

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR AN UNRELATED ALARM, THE PATIENT'S CAREGIVER INDICATED THE PATIENT HAD PERITONITIS POSSIBLY DUE TO THE CATHETER. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT'S PD NURSE ON (B)(6) 2011: THE PATIENT STARTED ON AUTOMATED PD THERAPY WITH LOCAL (PD4) AMBUFLEX IN (B)(6) 2010. THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2011 AND WAS HOSPITALIZED. THE NURSE INDICATED THAT THE CAUSE OF THE PERITONITIS IS UNKNOWN, BUT IT WAS NOT RELATED TO THE CATHETER AS PREVIOUSLY INDICATED BY THE PATIENT'S CAREGIVER. THE NURSE INDICATED THAT THE PATIENT WAS DIAGNOSED WITH THE PERITONITIS, WAS GIVEN ANTIBIOTICS, AND HAD THE CATHETER REMOVED TO BE PLACED ON HEMODIALYSIS. THE NURSE INDICATED THE PATIENT HAS RECOVERED AND HAS BEEN ABLE TO CONTINUE ON HEMODIALYSIS WELL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R LOCAL (PD4) AMBUFLEX| HOMECHOICE CYCLER