BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2182153 · Received July 28, 2011

    Report

    Report Number
    6000001-2011-15223
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    April 28, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP EXPERIENCED AN UPSTREAM OCCLUSION ALARM AFTER ONE MINUTE OR MORE OF DELIVERY PRIOR TO AN OPEN KEY PRESS. THE OPEN KEY PRESS INDICATED THAT AN UNKNOWN SET WAS REPLACED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS COMPLAINT WILL ADDRESS THE POSSIBILITY THAT THE UNKNOWN SET WAS DEFECTIVE CAUSING THE UPSTREAM OCCLUSION ALARM. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED FOR THIS REPORT. THIS WAS NOT REPORTED BY THE CUSTOMER. NO ADDITIONAL INFORMATION IS AVAILABLE. DEVICE EVALUATION: THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. TE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A MANUAL TUBE RELEASE OPEN KEY PRESS ALARM, WHICH INTERRUPTED DELIVERY. THIS ALARM MAY HAVE BEEN A FALSE ALARM. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1