BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    80 FRN

    MDR report key: 1210185 · Received October 20, 2008

    Report

    Report Number
    6000001-2008-00645
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF AN OVERINFUSION OF 100CC OF NORMAL SALINE TO A PATIENT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THE FACILITY CANNOT IDENTIFY THE PUMP AND WILL NOT BE ABLE TO LOCATE IT FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PRIMARY BAG INFUSED WHEN THE SECONDARY BAG WAS INTENDED TO INFUSE. AFTER 1L OF NORMAL SALINE WAS INFUSED, THE PRIMED CYTOTOXIN CHEMOTHERAPY BAG WAS HUNG WITH THREE EXTENDERS. AFTER APPROXIMATELY 100-200CC OF THE CHEMOTHERAPY DRUG INFUSED TO THE PATIENT AS INTENDED, THE HOSPITAL REPRESENTATIVE OBSERVED THE NORMAL SALINE WAS INFUSING INSTEAD OF THE CHEMOTHERAPY DRUG. APPROX 100CC OF NORMAL SALINE INFUSED TO THE PATIENT WHEN IT WAS NOT INTENDED. THIS CONDITION OCCURRED ON 09/17/2008 DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THIS CONDITION OCCURRED WITH AN UNKNOWN SINGLE CHANNEL COLLEAGUE INFUSION PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 80 FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1