BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1883544 · Received October 26, 2010

    Report

    Report Number
    6000001-2010-04532
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF AN ALARM WITH 1 MILLILITER LEFT IN THE SYRINGE. THE ROOT CAUSE WAS DETERMINED TO BE A PLUNGER SCREW WHICH WAS NOT SET CORRECTLY, RESULTING IN A PREMATURE END OF SYRINGE ALARM. THE PLUNGER SCREW WAS SET TO SPECIFICATION TO REPAIR THE REPORTED CONDITION. A SERVICE HISTORY REVIEW DETERMINED THAT THIS DEVICE HAS NOT PREVIOUSLY BEEN SERVICED BY BAXTER. A DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A INFUSE O.R. PUMP WHICH ALARMED DURING USE IN THE OPERATING ROOM, INTERRUPTING DELIVERY. THE DEVICE BEGAN ALARMING WITH 1 MILLILITER LEFT IN THE SYRINGE, STOPPED DELIVERING, AND BECAME INOPERABLE. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1