BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1478218 · Received September 22, 2009

    Report

    Report Number
    6000001-2009-00935
    Event Type
    Malfunction
    Date Received
    September 22, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 4, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WHICH SHUT OFF BY ITSELF. THIS DEVICE WAS EVALUATED AT THE FACILITY BY A BAXTER SERVICE TECHNICIAN. HOWEVER, THIS CONDITION COULD NOT BE CONFIRMED NOR DUPLICATED DURING PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE COULD BE GIVEN AND NO REPAIR WAS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B) (4). THIS PUMP WILL BE EVALUATED AND REPAIRED AT THE FACILITY BY A BAXTER SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT FROM LITERATURE: L.G. CLOSE, A.K. HSU, S. RICKERT, M. SHRIME, A. TABAEE (2006). SYNECHIA FORMATION AFTER ENDOSCOPIC SINUS SURGERY AND MIDDLE TURBINATE MEDIALIZATION WITH AND WITHOUT FLOSEAL. AMERICAN JOURNAL OF RHINOLOGY(2007) 21:174-179. SUMMARY OF ARTICLE FROM ABSTRACT: SOME PATIENTS UNDERWENT MEDIALIZATION WITH PLACEMENT OF FLOSEAL. A STATISTICALLY SIGNIFICANT HIGHER INCIDENCE OF SYNECHIA FORMATION WAS NOTED IN PATIENTS WHO UNDERWENT MIDDLE TURBINATE MEDIALIZATION WITH THE PLACEMENT OF FLOSEAL (18.9%).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP WHICH SHUT OFF BY ITSELF. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. 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