BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4121528 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33344
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A RETAINED SAMPLE WAS EVALUATED AND VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE SET WITH AN INFUSION PUMP WERE COMPLETED. VISUAL INSPECTION AND FUNCTIONAL TESTING DID NOT REVEAL ANY ABNORMALITIES RELATED TO THE REPORTED CONDITION. THE RETAINED SET WAS CONFORMING AS PER PRODUCT SPECIFICATIONS AND THE REPORTED DEVIATION COULD NOT BE CONFIRMED VIA SAMPLE¿S ANALYSIS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. HOWEVER, IT WAS REPORTED BY A BAXTER¿S SALES REPRESENTATIVE THAT THIS CONDITION WAS GENERATED BY USER ERROR. IN ORDER TO ADDRESS THIS CONDITION THE INVOLVED PERSONNEL WERE GIVEN AWARENESS TRAINING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A LIGHT SENSITIVE DRUG SET THAT WAS INSERTED INTO AN UNKNOWN INFUSION PUMP WAS TOO LARGE AND EXPOSED THE MEDICATION TO LIGHT. A BAXTER SALES REPRESENTATIVE (BSR) LATER VISITED THE REPORTING CLINIC AND DISCOVERED THAT THE SET WAS INCORRECTLY INSERTED INTO THE PUMP, CAUSING THE TUBING TO STRETCH. THIS WAS NOTED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601568 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 12C23V715

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INFUSION PUMP