BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3892372 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20128
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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). EVALUATION SUMMARY: THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER. DURING THE INSPECTION OF THE PHOTOGRAPH A HOLE WAS IDENTIFIED IN THE TUBING. THE CAUSE OF THE HOLE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE SAMPLE IS REPORTED TO BE UNAVAILABLE FOR EVALUATION. HOWEVER, 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). THE REPORTER STATED THAT THE FACILITY USES AN UNKNOWN SINGLE CHANNEL PUMP FOR INFUSIONS. THE PUMP IS PLACED IN A HOLDER ABOVE THE INCUBATOR. THE PARENTERAL NUTRITION BAG WAS STORED IN A REFRIGERATOR AND THEN MANUALLY WARMED PRIOR TO INFUSION. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LIGHT SENSITIVE DRUG SET LEAKED DURING INFUSION. ACCORDING TO THE REPORT, THIS EVENT OCCURRED DURING THE INFUSION OF PARENTERAL NUTRITION ON ONE INFANT PATIENT. THIS WAS REPORTED TO HAVE OCCURRED THREE TIMES ON THE SAME PATIENT. THE LOCATION OF THE LEAK WAS NOT REPORTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT TWO OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367882 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 13L04V790

    Patients

    Seq Age Sex Outcome Treatment
    1 PARENTERAL NUTRITION| UNKNOWN PUMP