BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4252312 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40778
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 14G050 WAS MANUFACTURED JULY 23, 2014 TO JULY 25, 2014. THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION ON THE DEVICE (VIA THE NAKED EYE) NOTED A SOLID WHITE PARTICLE APPROXIMATELY 1.06 MM IN LENGTH, FLOATING IN THE FLUID PATHWAY OF THE RESERVOIR. BOTH VISUAL AND MICROSCOPIC INSPECTION PERFORMED ON THE DEVICE. THE PARTICLE WAS IDENTIFIED TO BE POLYESTER MATERIAL VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) SPECTROPHOTOMETER SCANNING. THE REPORTED CONDITION WAS VERIFIED, THOUGH NO CAUSE COULD NOT BE DETERMINE WITH THE PROVIDED INFORMATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HALF DAY INFUSOR HAD PARTICULATE MATTER INSIDE OF ITS BLADDER. THIS WAS IDENTIFIED DURING OR AFTER FILLING WITH DESFERRIOXAMINE AND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737396 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14G050

    Patients

    Seq Age Sex Outcome Treatment
    1