BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2142095 · Received June 28, 2011

    Report

    Report Number
    6000001-2011-09104
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    March 19, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A POTENTIAL FREEFLOW WAS NOT CONFIRMED OR DUPLICATED BY BAXTER SERVICE PERSONNEL BECAUSE THE DEVICE WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION. NO CAUSE CAN BE DETERMINED AND NO REPAIRS NEEDED TO CORRECT THIS CONDITION. A DEVICE HISTORY REVIEW REVEALED NO ABNORMALITIES WERE FOUND DURING MANUFACTURING. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NO PRIOR SERVICE HISTORY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN A MEDWATCH RECEIVED FROM GLOBAL PHARMACOVIGILANCE ON JUNE 6, 2011, A CUSTOMER REPORTED THAT PROTONIX DRIP AND IV ANTIBIOTICS WERE HUNG AT APPROXIMATELY 13:30 USING A FLO-GARD 6201 INFUSION PUMP. THE PUMP WAS PROGRAMMED FOR PROTONIX AT 10CC AND FOR AZITHROMYCIN AT 255CC. NO INFUSION TIME WAS GIVEN BY THE CUSTOMER. THE CUSTOMER RETURNED WITHIN AN HOUR AND FOUND BOTH IV BAGS DRY AND THE PUMP BEEPING FOR AIR IN LINE (ADDRESSED IN (B)(4)). THIS REPORT IS BEING SENT FOR THE FREEFLOW CONDITION. CUSTOMER STATES THAT THE RATES WERE RE-CHECKED AND WERE AT 10CC AND 255CC, RESPECTIVELY. THE CUSTOMER STATED THAT IT WAS NOT KNOWN IF THE BAGS WERE HUNG PROPERLY. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY IN REGARDS TO THE REPORTED EVENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 PROTONIX, AZITHROMYCIN