BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3841356 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17446
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 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). MANUFACTURED NOVEMBER 18, 2013 ¿ NOVEMBER 19, 2013. EVALUATION INFORMATION: THE SAMPLE WAS RECEIVED FOR EVALUATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED FOR LOT NUMBER 13M069 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. A VISUAL INSPECTION IDENTIFIED THAT THERE WAS FLUID INSIDE OF THE HOUSING. SPECTROSCOPIC ANALYSIS IDENTIFIED THAT THE SOLUTION WAS WATER. THE DEVICE WAS FILLED WITH GREEN WATER IN ORDER TO PERFORM A LEAK TEST. THE DEVICE DID NOT LEAK DURING FILLING OR AFTER SITTING UNTIL THE NEXT DAY. THE DEVICE WAS SUBMERGED UNDER WATER FOR ONE MINUTE. THE WATER WAS OBSERVED TO ENTER THE HOUSING THROUGH THE TOP AREA BY THE COILED CAP. THE TOP AREA IS NOT DESIGNED TO BE COMPLETELY SEALED; THEREFORE FLUID CAN ENTER THE HOUSING. THE CAUSE OF THE WATER IS UNKNOWN. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE MET SPECIFICATION DURING EVALUATION AND NO DEFECTS WERE IDENTIFIED. 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 A SMALL VOLUME INFUSOR HAD WATER DROPLETS ON IT AND WAS WET, INDICATING A POTENTIAL LEAK. THIS WAS NOTICED DURING PATIENT INFUSION OF AN UNKNOWN DRUG. THE REPORTER STATED THAT A FILTER WAS NOT USED DURING FILLING AND THE BLADDER DID NOT APPEAR TO BE DAMAGED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319484 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13M069

    Patients

    Seq Age Sex Outcome Treatment
    1