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Class 2 Device Recall Prometra II Programmable Infusion Pump |
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Date Initiated by Firm |
May 22, 2017 |
Date Posted |
June 19, 2017 |
Recall Status1 |
Terminated 3 on June 28, 2018 |
Recall Number |
Z-2740-2017 |
Recall Event ID |
77442 |
PMA Number |
P080012 |
Product Classification |
Pump, infusion, implanted, programmable - Product Code LKK
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Product |
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). |
Code Information |
All |
Recalling Firm/ Manufacturer |
Flowonix Medical, Inc. 500 International Dr Ste 200 Mount Olive NJ 07828-1381
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For Additional Information Contact |
Karen E. Matis 973-426-9229
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Under Investigation by firm |
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. |
Quantity in Commerce |
US: 2204 units |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LKK and Original Applicant = Algorithm Sciences, Inc.
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