BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3943616 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23209
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AGE OF THE PATIENT IS UNKNOWN; HOWEVER IT IS KNOWN THAT IT WAS A "NEWBORN". THE SET WAS BEING USED WITH AN UNKNOWN PUMP AT THE TIME OF THE MALFUNCTION. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. THE VISUAL INSPECTION SHOWED NO DEFECTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. DURING GRAVITY TESTING A LEAK WAS OBSERVED FROM A MICRO HOLE IN THE PUMP TUBING. THE REPORTED PROBLEM WAS VERIFIED. NO CAUSE COULD BE DETERMINED. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIGHT SENSITIVE DRUG SET LEAKED. THIS OCCURRED DURING PATIENT INFUSION OF PARENTERAL NUTRITION. THE REPORTER STATED THAT THE PART OF THE TUBING THAT WAS INSERTED INTO THE PUMP PRESENTED THE LEAK. 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
    422356 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 12L06V737

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED INFUSION PUMP| TOTAL PARENTERAL NUTRITION