BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW RECIRCULATION VOLUME APOSET W/CASSETTE

    MDR report key: 1961956 · Received January 15, 2011

    Report

    Report Number
    1423500-2011-00687
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT (H10J05031) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR - POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR(S) IDENTIFIED IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS ARE INSTRUCTED TO DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF A PATIENT THAT DEVELOPED PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A (B)(6) OLD MALE PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT THE PATIENT MADE A MISTAKE/ TOUCH CONTAMINATION (DATE OF ONSET NOT REPORTED). ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. TREATMENT FOR THE EVENTS WERE NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL PD2 AMBUFLEX THERAPY WAS DISCONTINUED. PER THE NURSE, THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO DIANEAL PD2 AMBUFLEX THERAPY BUT RATHER DUE TO TOUCH CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW RECIRCULATION VOLUME APOSET W/CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R