BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INFUSIONPUMP

    MDR report key: 1212325 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88975
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 31, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 25, 2007. THE FACILITY REPRESENTATIVE REPORTED A ¿OCCLUSION LEVEL STOPPED¿. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. EVALUATION SUMMARY: THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. INSPECTION OF THE DEVICE FOUND THAT THE OCCLUSION ALARM WAS CAUSED BY BROKEN DOOR HINGES ON CHANNEL 1. THE DOOR ASSEMBLY WAS REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, BROKEN DOOR HINGES ON CHANNEL 1 WERE FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INFUSIONPUMP 80FRN FRN BAXTER HEALTHCARE (SG) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1