BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK EXT SET WITH 3 PORTMANIFOLD

    MDR report key: 1832270 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03111
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. LOT NUMBER IS NOT KNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING BELOW THE Y-SITE AT THE CONNECTION TO THE TUBING. THE CONDITION WAS OBSERVED IN SAME DAY SURGERY. THE SETS ARE PRIMED THERE FOR THE UPCOMING SURGERYS. THE NURSE PRIMED IT AND THE LEAK OCCURRED RIGHT AWAY. THIS SET-UP INCLUDED LACTATED RINGERS CONNECTED TO AN UNKNOWN PRIMARY SET WHICH IS CONNECTED TO THE (B)(4).THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK EXT SET WITH 3 PORTMANIFOLD STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1