BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 2003118 · Received February 28, 2011

    Report

    Report Number
    6000001-2011-01412
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    December 10, 2010
    Report Date
    February 16, 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). CORRECTION: FAILURE CODE IN DEVICE EVALUATION WAS INCORRECT. DEVICE EVALUATION STATED, "THE CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 12 WAS DISCOVERED AND CONFIRMED DURING PRODUCT EVALUATION IN THE PUMP'S ALARM LOG." IT SHOULD HAVE STATED, "THE CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 3 WAS DISCOVERED AND CONFIRMED DURING PRODUCT EVALUATION IN THE PUMP'S ALARM LOG." ADDITIONAL INFORMATION: 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 12 WAS DISCOVERED AND CONFIRMED DURING PRODUCT EVALUATION IN THE PUMP'S ALARM LOG. NO ASSIGNABLE CAUSE CAN BE PROVIDED FOR THIS CONDITION. THEREFORE, NO REPAIR WAS NECESSARY FOR THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. 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 3, WHICH IS A DOWNSTREAM OCCLUSION ALARM. FURTHERMORE, BAXTER PERSONNEL DISCOVERED THIS DEVICE'S DOOR ASSEMBLY HAD A BROKEN LATCH STOP AND A CRACKED UPPER HINGE, 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