BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2120628 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07499
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER DISCONTINUED SERVICE AND CEASED ALL DESIGN RELATED SUPPORT ON FLO-GARD (B)(4) IN THE U.S. REGION AS OF (B)(6), 2010. BAXTER WILL CONTINUE TO COLLECT PRODUCT COMPLAINTS, BUT PERIODIC MONITORING/TRENDING AND ANALYSES OF THE U.S. COMPLAINTS FOR PRODUCT IMPROVEMENTS WILL NO LONGER BE REQUIRED. BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES TO ASSESS THE IMPACT ON PATIENT SAFETY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS DEVICE WAS NOT SENT TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WHICH DID NOT DETECT A DOWNSTREAM OCCLUSION CANNOT BE CONFIRMED OR DUPLICATED. NO ASSIGNABLE CAUSE CAN BE DETERMINED, AND NO REPAIRS MADE TO CORRECT THE CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WHICH DID NOT DETECT A DOWNSTREAM OCCLUSION DURING INFUSION ON A PATIENT (CANINE). ACCORDING TO THE FACILITY REPRESENTATIVE, ALTHOUGH THE DEVICE INDICATED THAT IT WAS PUMPING, NO (OR LITTLE) MEDICATION WAS BEING DELIVERED BECAUSE THE DOG WAS ON THE LINE. DUE TO THIS, THE PATIENT RECEIVED 300ML LESS OF DOXYCYCLINE THAN INTENDED. THE FACILITY REPRESENTATIVE STATED THAT 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 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 DOXYCYCLINE