BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3241596 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19371
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED WHICH REVEALED NO ISSUES RELATED TO THE REPORTED CONDITION. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET MAY HAVE EXPERIENCED A BACKFLOW. A BAG OF PIPERACILLIN HAD ALREADY BEEN HOOKED UP WHEN THE NURSE INADVERTENTLY FORGOT TO CLAMP OFF THE PRIMARY TUBING. THE RN WAITED 4-5 HOURS TO INFUSE THE PIPERACILLIN DUE TO THE UNCERTAINTY OF WHETHER THE PATIENT HAD RECEIVED THE ANTIBIOTIC INFUSION, OR, IF THE PIPERACILLIN COMPLETELY INFUSED INTO THE PRIMARY IV SOLUTION BAG. THERAPY WAS RESUMED USING A DIFFERENT PUMP. THE PATIENT DID NOT EXPERIENCE AN INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340438 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13B28119

    Patients

    Seq Age Sex Outcome Treatment
    1 PIPERACILLIN, UNKNOWN PRIMARY SOLUTION BAG| CLEARLINK NON-DEHP SECONDARY SET| SIGMA SPECTRUM PUMP