BEUDAMED
    FDA Adverse Event Summary report: N

    BAXA 099 REPEATER PUMP

    MDR report key: 2958893 · Received February 13, 2013

    Report

    Report Number
    1419106-2013-00001
    Date Received
    February 13, 2013
    Date of Event
    October 30, 2012
    Report Date
    January 18, 2013
    Manufacturer
    BAXTER CORPORATION ENGLEWOOD
    Product Code
    NEP
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE TESTED. RESULT: NO FAILURE DETECTED, DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THERE WAS NO ADVERSE EVENT INVOLVED WITH THIS REPORT. IT IS BAXTER CORPORATION (B)(4) PROCEDURE TO FILE A MDR ANYTIME WE BECOME AWARE THAT A MEDWATCH REPORT HAS BEEN FILED WHICH REFERENCES ONE OF OUR DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, BAXTER CORPORATION (B)(4) RECEIVED A COPY OF A 3500A MEDWATCH FORM (MDR) SENT BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (FDA) THAT WAS FILED BY ONE OF OUR REPEATER PUMP CUSTOMERS. THE POSTMARK ON THE ENVELOPE IS (B)(6), 2013. THE EVENT DESCRIPTION OF THE MDR DESCRIBES A DISCREPANCY IN THE VOLUME REMAINING IN A PCA CASSETTE AFTER DELIVERING INGREDIENT TO THE PATIENT FROM A 100ML BAG. THE SUSPECT MEDICAL DEVICE REFERENCED LISTS AN INFUSION PUMP MANUFACTURED BY ANOTHER COMPANY. THE REPEATER PUMP IS LISTED AS A CONCOMITANT DEVICE. THE REPEATER PUMP IS USED IN THE PHARMACY LAB TO TRANSFER INGREDIENTS FROM ONE CONTAINER TO ANOTHER. IN (RELEVANT TESTS) OF THE MDR THERE IS DOCUMENTATION DESCRIBING THE TESTING THE CUSTOMER PERFORMED (B)(6) 2012 ON THE REPEATER PUMP. THEY STATE THAT WHEN THEY PERFORMED CALIBRATION AT EVERY FILL/PROCEDURE THE PUMP DELIVERED THE APPROPRIATE AMOUNT OF FLUID AS EXPECTED. WHEN TESTING WAS DONE WITHOUT CALIBRATION THEY NOTICED AN OFFSET IN VOLUME OF 2-3 CC AFTER 17-28 FILLS. THIS PUMP WAS RETURNED TO BAXTER CORPORATION FOR EVALUATION AND PASSED ALL ACCURACY TESTS AT THE CUSTOMER SPECIFIED VOLUME OF 100ML. THE TESTING VERIFIES THAT IF PROPERLY CALIBRATED PRIOR TO USE, THE PUMP OPERATES AS INTENDED. THERE WAS NO ADVERSE EVENT INVOLVED WITH THIS REPORT. IT IS BAXTER CORPORATION (B)(4) PROCEDURE TO FILE A MDR ANYTIME WE BECOME AWARE THAT A MEDWATCH REPORT HAS BEEN FILED WHICH REFERENCES ONE OF OUR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62697 BAXA 099 REPEATER PUMP REPEATER PUMP NEP BAXTER CORPORATION ENGLEWOOD 099

    Patients

    Seq Age Sex Outcome Treatment
    1