BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1905289 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05167
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. UPON COMPLETION OF BAXTER?S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "OCCLUSION ALARM-FALSE". (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF OCCLUSION ERROR BUT NO ACTUAL OCCLUSIONS WERE PRESENT WAS CONFIRMED DUE TO PERVASIVE FLUID INTRUSION IN PUMP HEAD ASSEMBLY CAUSING THE DOWNSTREAM OCCLUSION SENSOR TO STICK INTERMITTENTLY. THIS DEVICE WILL BE RETURNED UNREPAIRED, DUE TO ESTIMATE REFUSAL BY THE CUSTOMER. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD PUMP WITH AN OCCLUSION ERROR BUT NO ACTUAL OCCLUSIONS WERE PRESENT. THE REPORTED CONDITION OCCURRED DURING PROGRAMMING/SETUP IN THE PHARMACY AREA. THERE WAS NO PATIENT INVOLVEMENT. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. 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