BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4033233 · Received August 25, 2014

    Report

    Report Number
    1416980-2014-27906
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    July 30, 2014
    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). THE LOT WAS MANUFACTURED BETWEEN JANUARY 14, 2014 AND JANUARY 15, 2014. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION NOTED A RUPTURED RESERVOIR. MICROSCOPIC EXAMINATION OF THE RESERVOIR IDENTIFIED A MARKING ON ITS INTERIOR SURFACE, NEAR THE RUPTURE LINE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A LARGE VOLUME INTERMATE DEVICE RUPTURED. THIS OCCURRED AT THE END OF THE INFUSION OF AN UNSPECIFIED DRUG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510765 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14A034

    Patients

    Seq Age Sex Outcome Treatment
    1