BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3840778 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17405
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERAPY DATE: THE EXACT DATE IS UNKNOWN; HOWEVER THE CUSTOMER DID STATE THAT THE EVENT OCCURRED IN APRIL. THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE OF THE RUPTURED INTERMATE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN APRIL 5, 2012 AND APRIL 6, 2012. ONE DEVICE WAS RECEIVED AND EVALUATED AGAINST THE REPORTED CONDITION OF A RUPTURED RESERVOIR. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION VERIFIED THE RUPTURED RESERVOIR. THE RESERVOIR WAS MICROSCOPICALLY EXAMINED AND A MARKING WAS OBSERVED ON THE INSIDE OF THE RUPTURED RESERVOIR. THE CAUSE COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE¿S RESERVOIR RUPTURED DURING THERAPY. THE MALFUNCTION OCCURRED DURING THE INFUSION OF A NON-BAXTER DRUG. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318674 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12D006

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLU-MEDROL