BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 200, 48 PACK,50125

    MDR report key: 1911247 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05349
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE UNIT WAS RECEIVED BY BAXTER FOR EVALUATION CONTAINING APPROXIMATELY 105ML OF FLUID IN THE RESERVOIR. NO SIGNS OF ABNORMALITY WERE OBSERVED ON THE DEVICE UPON SAMPLE RECEIPT. THE FILL-PORT CAP WAS REMOVED, BUT NO SIGNS OF BUBBLES OR FOAM WERE DETECTED AT THE FILL-PORT. NO SIGNS OF ABNORMALITY WERE NOTED ON THE FILL-PORT. THE FLUID IN THE RESERVOIR WAS SUBSEQUENTLY DRAINED THEN MANUALLY REFILLED WITH SALINE SOLUTION. DURING AND AFTER FILL, NO SIGNS OF BUBBLES OR FOAM WERE OBSERVED AT THE FILL-PORT. THE REPORTED CONDITION COULD NOT BE CONFIRMED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INTERMATE SV 200 DEVICE WAS PRODUCING "BUBBLES AND FOAM" AT THE LOCATION OF THE FILL PORT DURING FILLING. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE SV 200, 48 PACK,50125 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10D035

    Patients

    Seq Age Sex Outcome Treatment
    1