FLOWONIX (PROMETRA) INTRATHECAL PAIN PUMP
Report
- Report Number
- MW5107285
- Event Type
- Injury
- Date Received
- February 7, 2022
- Date of Event
- May 15, 2019
- Report Date
- February 3, 2022
- Manufacturer
- FLOWONIX MEDICAL, INC.
- Product Code
- LKK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
PATIENT PRESENTED TO THE CLINIC WITH A FLOWONIX INTRATHECAL PAIN PUMP. FOLLOWING PROTOCOL BEFORE AN MRI WITH THIS PUMP, THE MEDICATION WAS REMOVED FROM THE PUMP AND 10.9 ML WAS REMOVED, WHICH WAS WITHIN NORMAL PARAMETERS OF THE EXPECTED AMOUNT, AND THE PUMP'S RESERVOIR VOLUME WAS SET TO 0 ML, AND RATE WAS SET TO RUN AT 0 ML/DAY. PATIENT CAME BACK EARLY AFTERNOON TO PUT 20 ML OF NEW MEDICATION BACK INTO THE PUMP. PUMP WAS ACCESSED AND A 15 SECOND PULL BACK AND 2 ML OF FLUID WAS REMOVED, AFTER A SECOND PULL BACK 1 ML WAS REMOVED, AND AFTER A 3RD PULL BACK 1 ML WAS REMOVED. AFTER A FULL 1 MINUTE ASPIRATION 4.7 ML WAS REMOVED. FOR SAFETY, 20 ML OF NORMAL SALINE WAS PUT BACK IN THE PUMP AND PATIENT'S RATE WAS SET BACK TO THE ORIGINAL SETTING, AND WE MONITOR PATIENT. HE BEGAN HAVING OPIOID WITHDRAWAL SYMPTOMS: N/V, SWEATING AND HIS PULSE OX AT ROOM AIR WAS 88% WITH NO HISTORY OF LUNG ISSUES. WE SENT PATIENT TO THE ER. FLOWONIX RECOMMENDED TAKING THE NACL OUT DUE TO A POTENTIAL FAULTY VALVE FOLLOWING THE MRI BUT WE HAD ALREADY D/C THE PATIENT TO ER. AFTER PATIENT'S ER VISIT, HE CAME BACK TO OUR CLINIC THAT EVENING. ZERO (0) ML WAS IN THE RESERVOIR WHEN WE HAD PLACED 20 ML OF NORMAL SALINE WITHIN A FEW HOURS. UPON ASPIRATION WITH A 1 MINUTE PULL BACK 1 ML OF FLUID WAS NOTED AND AFTER ANOTHER 1 MINUTE ASPIRATION 2 ML OF FLUID WAS NOTED. PATIENT WAS REFERRED TO A SURGEON TO HAVE THIS PUMP REMOVED DUE TO A FAULTY VALVE POST MRI. THIS PATIENT HAD THE FLOWONIX INTRATHECAL PUMP FOR A TOTAL OF 6 YEARS. FLOWONIX GENERALLY LAST 10 YEARS BUT CAN LAST LONGER. FDA SAFETY REPORT ID # (B)(4).
PATIENT PRESENTED TO THE CLINIC WITH A FLOWONIX INTRATHECAL PAIN PUMP. FOLLOWING PROTOCOL BEFORE AN MRI WITH THIS PUMP, THE MEDICATION WAS REMOVED FROM THE PUMP AND 10.9 ML WAS REMOVED, WHICH WAS WITHIN NORMAL PARAMETERS OF THE EXPECTED AMOUNT, AND THE PUMP'S RESERVOIR VOLUME WAS SET TO 0 ML, AND RATE WAS SET TO RUN AT 0 ML/DAY. PATIENT CAME BACK EARLY AFTERNOON TO PUT 20 ML OF NEW MEDICATION BACK INTO THE PUMP. PUMP WAS ACCESSED AND A 15 SECOND PULL BACK AND 2 ML OF FLUID WAS REMOVED, AFTER A SECOND PULL BACK 1 ML WAS REMOVED, AND AFTER A 3RD PULL BACK 1 ML WAS REMOVED. AFTER A FULL 1 MINUTE ASPIRATION 4.7 ML WAS REMOVED. FOR SAFETY, 20 ML OF NORMAL SALINE WAS PUT BACK IN THE PUMP AND PATIENT'S RATE WAS SET BACK TO THE ORIGINAL SETTING, AND WE MONITOR PATIENT. HE BEGAN HAVING OPIOID WITHDRAWAL SYMPTOMS: N/V, SWEATING AND HIS PULSE OX AT ROOM AIR WAS 88% WITH NO HISTORY OF LUNG ISSUES. WE SENT PATIENT TO THE ER. FLOWONIX RECOMMENDED TAKING THE NACL OUT DUE TO A POTENTIAL FAULTY VALVE FOLLOWING THE MRI BUT WE HAD ALREADY D/C THE PATIENT TO ER. AFTER PATIENT'S ER VISIT, HE CAME BACK TO OUR CLINIC THAT EVENING. ZERO (0) ML WAS IN THE RESERVOIR WHEN WE HAD PLACED 20 ML OF NORMAL SALINE WITHIN A FEW HOURS. UPON ASPIRATION WITH A 1 MINUTE PULL BACK 1 ML OF FLUID WAS NOTED AND AFTER ANOTHER 1 MINUTE ASPIRATION 2 ML OF FLUID WAS NOTED. PATIENT WAS REFERRED TO A SURGEON TO HAVE THIS PUMP REMOVED DUE TO A FAULTY VALVE POST MRI. THIS PATIENT HAD THE FLOWONIX INTRATHECAL PUMP FOR A TOTAL OF 6 YEARS. FLOWONIX GENERALLY LAST 10 YEARS BUT CAN LAST LONGER. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89885 | FLOWONIX (PROMETRA) INTRATHECAL PAIN PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | FLOWONIX MEDICAL, INC. | VERSION 0.26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other| H |