BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM

    MDR report key: 2002578 · Received February 28, 2011

    Report

    Report Number
    6000001-2011-01392
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    September 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). EVALUATION SUMMARY: AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION FOR THE REPORTED CONDITION OF A "COLLAPSED SEPTUM." A VISUAL INSPECTION OF THE SAMPLE REVEALED THE SEPTUM WAS COLLAPSED INSIDE THE THIRD INTERLINK Y-SITE FROM THE CHAMBER. A COMPLETE HOT STAMP WAS OBSERVED ON THE INTERLINK HOUSING AND A DIMENSIONAL INSPECTION WAS PERFORMED ON THE SWAGE HEIGHT WITH NO OTHER ANOMALIES OBSERVED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER, AN INTERLINK SYSTEM SOLUTION SET IN WHICH THE SEPTUM COLLAPSED. THIS INCIDENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1