BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1914724 · Received December 3, 2010

    Report

    Report Number
    6000001-2010-05474
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    June 22, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 2 WAS DISCOVERED AND CONFIRMED THROUGH PUMP'S ALARM LOG BUT WAS NOT DUPLICATED DURING PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE CAN BE PROVIDED AND NO REPAIR WAS NECESSARY FOR THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING REVIEW OF THE PUMP'S ALARM LOG, BAXTER PERSONNEL DISCOVERED A FLO-GARD INFUSION PUMP WITH FAILURE CODE 2, WHICH IS A DOWNSTREAM OCCLUSION ALARM. THIS FAILURE CODE OCCURRED SIX TIMES ON THE OCCURRENCE DATE. FURTHERMORE, BAXTER PERSONNEL DISCOVERED THIS DEVICE'S DOOR ASSEMBLY HAD A BROKEN LATCH, INDICATING A FALSE OCCLUSION ALARM. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1