BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE PUMP SETS WITH CARESITE

    MDR report key: 3883973 · Received February 14, 2014

    Report

    Report Number
    9614279-2014-00001
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 20, 2014
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. IF THE SAMPLE IS RECEIVED FOR EVALUATION OR IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY, REPORTS THE SET LEAKED FROM THE Y-SITE. CHEMOTHERAPY WAS INFUSING CAUSING A CHEMO SPILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98032 INFUSOMAT SPACE PUMP SETS WITH CARESITE UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV FRN B. BRAUN DOMINICAN REPUBLIC NA 0061335677

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK