BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4130322 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33909
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE LOT WAS MANUFACTURED ON MAY 6, 2014 ¿ MAY 7, 2014. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. VISUAL INSPECTION OF THE DEVICE REVEALED A RUPTURED BLADDER. MICROSCOPIC TESTING WAS PERFORMED AND REVEALED MARKINGS ON THE EXTERIOR NEAR THE BLADDER RUPTURE LINE. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADDER OF A SMALL VOLUME INFUSOR RUPTURED. THE RUPTURED BLADDER DID NOT DETACH FROM THE ASSEMBLY AND WAS NOT IN THE FOOTED POSITION. THIS OCCURRED DURING FILLING WITH AN UNKNOWN DRUG USING A SYRINGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608261 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14E008

    Patients

    Seq Age Sex Outcome Treatment
    1