BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3944096 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23236
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN (B)(6) 2013. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, A PHOTO OF THE DEVICE WAS RECEIVED. UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF THE PHOTOS OF A LARGE VOLUME INFUSOR, A LEAK WAS IDENTIFIED INSIDE OF THE HOUSING. THE LEAK WAS NOT REPORTED AND WAS DIFFERENT FROM THE ORIGINALLY REPORTED CONDITION. SAME DEVICE AS (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, PHOTOGRAPHS OF THE DEVICE WERE RECEIVED AND EVALUATED. PHOTOGRAPHIC EXAMINATION IDENTIFIED LEAKAGE INSIDE OF THE HOUSING. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED 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. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED. THE REPORTER STATED THAT THE LEAK OCCURRED IN THE HOUSING, AFTER PRIMING. THE DEVICE WAS FILLED WITH BENZYLPENICILLIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422688 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13K088

    Patients

    Seq Age Sex Outcome Treatment
    1