BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2222034 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11192
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE PRODUCT CODE WAS UNKNOWN AND NO LOT NUMBER WAS PROVIDED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION OR BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED. AS THE PRODUCT CODE IS UNKNOWN, A 510K NUMBER WAS NOT ABLE TO BE IDENTIFIED.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED THROUGH BAXTER'S AFTER HOURS CALL SERVICE FROM A PATIENT WHO ATTENDS THE (B)(6) HOSPITAL. THE PATIENT CALLED TO REPORT A LOW DRAIN VOLUME ALARM, AND INDICATED HE HAD JUST BEEN DISCHARGED FROM THE HOSPITAL AFTER EXPERIENCING PERITONITIS. IT IS UNKNOWN WHAT LABS OR CULTURES WERE PERFORMED. IT IS UNKNOWN WHAT INTERVENTIONS WERE REQUIRED. IT IS UNKNOWN WHAT CAUSED THE PERITONITIS. THE PATIENT OUTCOME WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization HOMECHOICE