BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1830216 · Received September 10, 2010

    Report

    Report Number
    6000001-2010-03092
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT THE MEDICAL DEVICE REPORT FOR THIS CONDITION WAS DOCUMENTED IN MANUFACTURER REPORT NUMBER 6000001-2010-03496.

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE BEEN DISCARDED BY THE CUSTOMER; THEREFORE A BAXTER EVALUATION WILL NOT BE PERFORMED. LOT NUMBER IS NOT KNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SET THAT WAS FOUND LEAKING FROM THE CHECK VALVE MORE THAN AN HOUR AFTER THE IV WAS STARTED. THE REPORTED CONDITION OCCURRED DURING PATIENT USE. ALL CONNECTIONS APPEARED TO BE SECURE. 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