BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP

    MDR report key: 1212988 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-81052
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    July 3, 2007
    Report Date
    July 5, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 31, 2007. THE FACILITY REPRESENTATIVE REPORTED A ¿RIGHT DOOR BROKEN¿ DURING BIO-MED TESTING. EVALUATION SUMMARY: THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. THE REPORTED CONDITION OF ¿RIGHT DOOR BROKEN" WAS CONFIRMED. PUMP #1 DOOR ASSEMBLY WAS FOUND CRACKED. 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, PUMP #1 DOOR ASSEMBLY WAS FOUND CRACKED. ACCORDING TO THE FACILITY REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1