BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4002182 · Received August 12, 2014

    Report

    Report Number
    1416980-2014-26150
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A GRAVITY TEST WAS THEN PERFORMED, AND THE SOLUTION CORRECTLY FLOWED THROUGH THE TUBING WITH NO AIR BUBBLES DETECTED. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLOOD ADMINISTRATION SET WITH CLEARLINK HAD AN AIR BUBBLE IN THE LINE. THIS OCCURRED DURING INFUSION OF 1.5L 5% INTRAVENOUS DEXTROSE WITH 40MMOL 7.45% POTASSIUM CHLORIDE. THE REPORTER STATED THAT THE TOTAL VOLUME OF THE SOLUTION IN THE INFUSION BAG WAS 540ML, AND THE INFUSION WAS SET TO COMPLETE IN 8 HOURS. THE DEVICE WAS BEING USED WITH A COLLEAGUE INFUSION PUMP. IT WAS REPORTED THAT THE SIZE OF THE BUBBLE WAS BETWEEN 1 AND 1.5 CM, AND THE BUBBLE WAS DETECTED BY THE PATIENT BEFORE IT WENT INTO THE PERIPHERALLY INSERTED CENTRAL CATHETER LINE. 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
    479926 ACCESS SET, BLOOD TRANSFUSION BRZ BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 14B11V370

    Patients

    Seq Age Sex Outcome Treatment
    1 7.45% POTASSIUM CHLORIDE| PERIPHERALLY INSERTED CENTRAL CATHETER LINE| 5% INTRAVENOUS DEXTROSE| COLLEAGUE INFUSION PUMP