BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2935374 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02277
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE DAMAGE TO DOOR LATCH ROLLER. TO CORRECT THE CONDITION, THE DOOR LATCH ROLLER WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FLOGARD INFUSION PUMP THAT DID NOT WORK. DURING REVIEW OF THE DEVICE BY A SERVICE TECHNICIAN, THE REPORTED CONDITION WAS CONFIRMED AS A DOWNSTREAM OCCLUSION ALARM. IT IS UNKNOWN DURING WHICH STEP OR IN THE PROCESS AREA THAT THIS STEP OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THE EVENT. ADDITIONAL INFORMATION: (EVALUATION METHOD): A SERVICE HISTORY REVIEW REVEALED THAT THERE WERE NO PREVIOUS SERVICE EVENTS FOR THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED CONDITION IS AN OCCLUSION ALARM.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE AN OCCLUSION FALSE ALARM. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS WAS NOT REPORTED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40902 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN 2M8063F

    Patients

    Seq Age Sex Outcome Treatment
    1