BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS

    MDR report key: 3023666 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07450
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K960787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR FURTHER ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY RECENTLY SWITCHED FROM IRRIGATION SETS AND THE FACILITY WAS DISSATISFIED WITH THE LENGTH OF THE SET. THE CUSTOMER REPORTED THAT THE LENGTH OF THE NEW PRODUCT WAS TOO SHORT FOR THEIR SURGICAL SET-UPS. THE FACILITY BELIEVES THAT THE DIFFERENCE IN LENGTH RESULTED IN AN INFECTION DURING A PROCEDURE. FOLLOW UP INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THERE WERE 3 SEPARATE PATIENTS THAT HAD AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTIVE SURGICAL PROCEDURE (DATES NOT REPORTED). THE PHYSICIAN WAS USING BAXTER'S FOUR LEAD TUR IRRIGATION SET FOR THE INTENDED SURGERY DUE TO BAXTER PLACING A HOLD ON THE 4 LEAD ARTHROSCOPIC IRRIGATION SET. IT WAS REPORTED BY THE FACILITY NURSE MANAGER, BY USING THE FOUR LEAD TUR IRRIGATION SET, THE TUBING IS MUCH SHORTER THAN THE FOUR LEAD ARTHROSCOPIC IRRIGATION SET, CAUSING THE SOLUTION BAGS HUNG ON AN UNSTERILE IV POLE TO ENTER INTO A STERILE FIELD DURING THE SURGICAL PROCEDURE AND COMPROMISING STERILITY. THE FACILITY USES AN IV POLE TO HANG THE IRRIGATION SOLUTIONS DURING THE PROCEDURE. BOTH THE IV POLE AND THE SOLUTIONS ARE CONSIDERED TO BE UNSTERILE AND OUTSIDE OF THE STERILE FIELD. AS A RESULT OF THE COMPROMISE IN STERILITY ISSUES, ALL 3 PATIENTS RESULTED IN GETTING AN INFECTION WITH THE SAME ORGANISM (NOT REPORTED). ALL THREE PATIENTS WERE TREATED WITH ANTIBIOTIC THERAPY (NAME AND DOSE NOT REPORTED) BY IRRIGATION TO THE SURGICAL SITE, ORAL ANTIBIOTICS, AND UNDERWENT ANOTHER SURGICAL PROCEDURE TO REMOVE THE IMPLANT. AFTER ALL THREE PATIENTS WERE CONSIDERED TO BE RECOVERED FROM THE REPORTED INFECTION THEY UNDERWENT ANOTHER ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTIVE SURGICAL PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126927 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention