BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1896973 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05639
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10H05059 AND H10G13055) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT'S DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER (B)(4) DISCOVERED A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY DEPLETED ALARM, WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND FUNGAL PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE IN 2010, PD THERAPY WAS WITHDRAWN. THE PATIENT WAS RECOVERING FROM PERITONITIS. THE OUTCOME OF MADE A MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED.

    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 62 YR Hospitalization| R DIANEAL PD4 AMBUFLEX