BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4212155 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37964
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM JUNE 20, 2014 TO JUNE 21, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. A IRREGULARLY SHAPED BROWN PARTICLE, APPROXIMATELY 0.60 MM IN SIZE, WAS FOUND EMBEDDED IN THE STRESS MEMBER. THE REPORTED ISSUE WAS VERIFIED THROUGH EVALUATION. 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

    COMPLAINT NO: CMPLNT-(B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INFUSOR HAD BLACK PARTICULATE MATTER/STAIN LOCATED ON ITS BLADDER ¿NEAR THE CRIMP.¿ THIS WAS FOUND DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692381 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F042

    Patients

    Seq Age Sex Outcome Treatment
    1