BEUDAMED
    FDA Recall Terminated

    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).

    Recall: Z-2740-2017 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-2740-2017
    Event Number
    77442
    Firm
    Flowonix Medical, Inc.
    FEI Number
    3006803715
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 22, 2017
    Posted
    June 19, 2017
    Terminated
    June 28, 2018
    Address
    500 International Dr, Ste 200, Mount Olive, NJ, 07828-1381

    Description

    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).

    Reason

    Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.

    Action

    Flowonix sent an URGENT MEDICAL DEVICE CORRECTION Letter and Response Forms dated May 22, 2017, with updated instructions were sent via UPS 2nd Day Air on May 25, 2017 to healthcare professionals: physicians and MRI facilities and technicians. The documents will also be available at www.flowonix.com. A Correction Letter will also be sent to patients to inform them of the labeling changes. For further questions, please call (973) 426-9229.

    Distribution

    Nationwide Distribution

    Quantity

    US: 2204 units