BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK SYSTEM NON-DEHP MINIVOL 3 LEAD CATHETER EXT SET

    MDR report key: 1900185 · Received November 16, 2010

    Report

    Report Number
    6000001-2010-04912
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FPA
    PMA / PMN Number
    K915390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION/ADDITIONAL INFORMATION. THREE COMPANION SAMPLE WERE SUBMITTED FOR EVALUATION ON (B)(6) 2010. THREE COMPANION SAMPLES WERE SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED ON THE SAMPLES AND FOUND NO ABNORMALITIES. THE SAMPLES WERE THEN SUBMITTED FOR UNDERWATER PRESSURE TESTING AND NO LEAKS WERE OBSERVED. THE REPORTED CONDITION WAS NOT CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONCLUSION CODE WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A 3-LEAD INTERLINK SYSTEM CATHETER EXTENSION SET THAT HAD A SEPARATION BETWEEN THE TUBING AND THE LUER CLOSEST TO THE PATIENT. THIS INCIDENT INVOLVED AN INFUSION OF HYPERAL AND LIPIDS THAT WERE CONNECTED VIA CENTRAL LINE. A B BRAUN PUMP WAS USED AND THE PATIENT WAS A NEONATE. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK SYSTEM NON-DEHP MINIVOL 3 LEAD CATHETER EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1