BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2070008 · Received April 26, 2011

    Report

    Report Number
    6000001-2011-03190
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THIS DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT PRODUCT CODE IS UNKNOWN, BUT A 510K IS STILL PROVIDED AS IT IS THE SAME FOR BOTH POSSIBLE CODES. PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE RESULTS OF EVALUATION COULD NOT BE COMPLETED AND THE REPORTED CONDITION OF "NO FLOW/NON DELIVERY" COULD NOT BE CONFIRMED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Description of Event or Problem · 1

    IT WAS REPORTED TO (B)(4) HEALTHCARE UNITED STATES THAT ONE (1) CE INTERMATE SV100 DEVICE WOULD NOT PRIME DURING PRIMING. THERE WAS NO ADDITIONAL INFORMATION. THE CUSTOMER STATED THIS HAPPENED WITHIN THE LAST 6 MONTHS BUT DID NOT KNOW THE EXACT DATE. IN ADDITION, THE CUSTOMER DID NOT KNOW THE EXACT PRODUCT CODE BUT STATED IT WAS EITHER 2C1730K OR 2C1732K. THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1