BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3842106 · Received May 31, 2014

    Report

    Report Number
    1416980-2014-17573
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM NOVEMBER 18, 2013 TO NOVEMBER 19, 2013. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE REPORTED PROBLEM; BROKEN TUBING NEAR THE DISTAL LUER LOCK WAS IDENTIFIED, WHICH WOULD RESULT IN THE REPORTED LEAK. 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 OF THE BROKEN TUBING WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN INITIATED TO INVESTIGATE THE REPORTED PROBLEM OF THE LEAK. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE LEAKED. THE DEVICE HAD BEEN FILLED WITH PAMIDRONATE (90MG) IN SODIUM CHLORIDE (250ML). THE REPORTER STATED THAT APPROXIMATELY HALF OF THE SOLUTION HAD LEAKED INTO THE OVER-POUCH. THE LOCATION OF THE LEAK WAS NOT IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320263 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13M079

    Patients

    Seq Age Sex Outcome Treatment
    1