BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW ABSORPTION SET

    MDR report key: 1940909 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06313
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RECEIVED BY THE PLANT FOR EVALUATION. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACTUAL UNIT WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A LOW ABSORPTION SET THAT HAD A LEAK. ACCORDING TO THE REPORT, THE DISPOSABLE RUPTURE OCCURRED INSIDE THE CHANNEL OF AN UNKNOWN COLLEAGUE PUMP WHILE ADMINISTERING PARENTERAL NUTRITION CAUSING A STOPPAGE OF THE INFUSION. THE CONDITION WAS REPORTED TO HAVE OCCURRED DURING INFUSION ON A PATIENT. 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
    1 LOW ABSORPTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 08I27V748

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN COLLEAGUE PUMP| PARENTERAL NUTRITION