BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURAFLOW SYSTEM

    MDR report key: 5070191 · Received September 9, 2015

    Report

    Report Number
    3008782989-2015-00002
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 9, 2015
    Manufacturer
    CLEARFLOW INC
    Product Code
    OTK
    PMA / PMN Number
    K150042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PHYSICAL INSPECTION WAS CONDUCTED ON (B)(6) 2015. THE CLEARANCE WIRE ASSEMBLY OF THE DEVICE SHOWED SIGNIFICANT DEFORMATION INCONSISTENT WITH NORMAL USE. EXTERNAL FORCES, THE NATURE OF WHICH IS UNKNOWN AT THIS TIME, MAY HAVE CAUSED THE DAMAGE. ADDITIONAL ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE CLEARANCE LOOP PORTION OF THE PLEURAFLOW SYSTEM SEPARATED FROM THE CLEARANCE WIRE AND REMAINED INSIDE THE GUIDE TUBE PORTION OF THE DEVICE. THE GUIDE TUBE IS EXTERNAL TO THE PATIENT AND CONNECTS THE CHEST TUBE TO THE DRAINAGE CANISTER. THE GUIDE TUBE WAS REMOVED AND THE CHEST TUBE REMAINED AND CONTINUED DRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596247 PLEURAFLOW SYSTEM POWERED SUCTION PUMP, OTK, GBX OTK CLEARFLOW INC PF-32 8962-04

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR