BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1896894 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05623
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE, NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RECEIVED AND EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF THREE COMPLAINTS RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOT, GD875567, WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE PATIENT INITIALLY CALLED THE BAXTER REPRESENTATIVE FOR ASSISTANCE WITH A CASSETTE. DURING THE CALL THE PATIENT STATED HE WAS CURRENTLY HOSPITALIZED DUE TO AN INFECTION IN HIS ABDOMEN. THE PATIENT STATED THAT THIS IS THE SECOND TIME THE INFECTION HAS OCCURRED AND HE HAS BEEN HOSPITALIZED. THE PATIENT'S PERITONEAL CATHETER HAD BEEN REMOVED. DURING A FOLLOW UP CALL, THE FACILITY NURSE CONFIRMED THE PATIENT HAD THE PERITONEAL CATHETER REMOVED AND IS ON HEMO DIALYSIS. THE NURSE STATED THAT THE PATIENT HAS HAD TWO DOCUMENTED CASES OF PERITONITIS. THE NURSE STATED TO CONTACT HIS PHYSICIAN FOR FURTHER INFORMATION. THIS IS THE MASTER COMPLAINT FOR THE EVENT OF PERITONITIS.

    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 39 YR Hospitalization| R (B)(4) DIANEAL LOW CA 1.5% 6L/6L (B)(4) DIANEAL