BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1212367 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88910
    Event Type
    Injury
    Date Received
    October 29, 2008
    Date of Event
    June 8, 2007
    Report Date
    June 8, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 19, 2007. THE ACTUAL SAMPLE WAS DISCARDED. A REQUEST HAS BEEN MADE FOR COMPANION SAMPLES TO BE RETURNED FOR EVALUATION. SHOULD THE SAMPLES BE RETURNED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE CONTACTED BAXTER PRODUCT SURVEILLANCE TO REPORT OVER INFUSION DURING PATIENT USE. THE MEDICATION TO BE INFUSED WAS HEPARIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO UNKNOWN REASON. ACCORDING TO THE REPORTER THE INCIDENT TOOK PLACE IN 2007 DURING NIGHT SHIFT. THE NURSE THAT WAS IN CHARGE WITH THE PATIENT WAS NOT AVAILABLE FOR INTERVIEW, HOWEVER SHE WAS DESCRIBED AS VERY EXPERIENCE; THEREFORE IT IS VERY UNLIKELY THAT A USE ERROR OCCURRED. THE PATIENT MEDICAL HISTORY, ADMITTING DIAGNOSES OR CLINICAL OUTCOMES WERE NOT PROVIDED, HOWEVER, IT WAS REPORTED THAT PROTAMINE SULFATE WAS ADMINISTERED TO THE PATIENT IN ORDER TO NEUTRALIZE THE EFFECT OF HEPARIN. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM 80FPA FPA BAXTER HEALTHCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention