BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1896904 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05624
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    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 EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE THIRD OF THREE COMPLAINTS RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOTS, H10G19094 AND H10F10012, 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. THIS MDR WAS SUBMITTED ON (B)(6) 2011; HOWEVER, DUE TO A FAILED ACK3, THIS MDR IS BEING RESUBMITTED ON (B)(6) 2011.

    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 HIS 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 12 FOOT EXTENSION SET EASYLOCK CONNECTOR SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R (B)(4) DIANEAL LOW CA 1.5% 6L/6L (B)(4) DIANEAL