BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1971226 · Received January 26, 2011

    Report

    Report Number
    6000001-2011-00458
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 4, 2010
    Report Date
    January 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 2 WAS CONFIRMED DURING PRODUCT EVALUATION IN THE PUMP'S EVENT HISTORY. THIS CONDITION WAS CAUSED BY THE PUMP'S DOOR BEING CRACKED IN THE LATCH AREA. DUE TO AN ESTIMATE REFUSAL BY THE CUSTOMER, NO REPAIRS WERE MADE TO THIS PUMP AND IT WAS RETURNED UN-REPAIRED TO THE CUSTOMER. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. DURING PREVIOUS SERVICE, A WHITE DOOR SHIM SPACER WAS ADDED BEHIND THE SAFETY CLAMP PLATE ON THE DOOR. 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. FURTHERMORE, BAXTER PERSONNEL DISCOVERED THIS DEVICE'S DOOR WAS BROKEN IN THE LATCH AREA. IT WAS ALSO FOUND TO BE BROKEN AT THE UPPER AND LOWER HINGE STOPS, 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