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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

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FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 13827
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative
A review of the dhr, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Pending device return.Internal complaint # (b)(4).
 
Event Description
On (b)(6) 2020, a prometra ii pump 20 ml was explanted due to underinfusions.The patient experienced two or three underinfusions (dates and expected vs aspirated volumes unknown).The patient has not had any recent mri exposure or traumas to the pump site.Patient has no pain relief.Patient is reportedly in pain because no medication being delivered intrathecal.
 
Manufacturer Narrative
Additional information: a3, g1 (second address).Corrected information: d9, g1, h3, h6.Device was returned for additional evaluation and investigation.A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any nonconformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, confirming the alleged issue.Operation of the pump reservoir function was checked by filling the reservoir with 20 ml of sterile water for injection (swi) and allowing the reservoir's pressure to return the fluid into the syringe.The reservoir was refilled and the cap was flushed with 5 ml of swi.A demand bolus of 0.300 mg with a 1.00 mg/ml concentration over 16 minutes was programmed with a programmer.The pump successfully primed.The pump was programmed with a 1.994 mg daily dose multirate flow test over a 24-hour time period at 37°c for 1 day.The dispensed volume was 0 ml (0%) of the expected volume.The catheter access port and suture ring were removed and the pump was decontaminated a second time.The top cover of the pump was machined off and the valves' "pull open / hold open" currents were measured.The results confirmed that the inlet current required a higher current to pull open than the specification, and the outlet valve failed to produce a readable current signal to measure.This indicates that current needed to pull open far exceeds the design specification for the valve.The cause of the issue was confirmed.The pump failed to flow to specification with both the inlet and outlet valves requiring a higher pull open current than the designed specification.Internal complaint number: (b)(4).
 
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Brand Name
PROMETRA II PROGRAMMABLE PUMP
Type of Device
IMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive, nj
MDR Report Key9857290
MDR Text Key185915400
Report Number3010079947-2020-00219
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public(01)00810335020228(10)25822(17)200323
Combination Product (y/n)N
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/23/2020
Device Model Number13827
Device Catalogue Number13827
Device Lot Number25822
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2020
Initial Date Manufacturer Received 03/09/2020
Initial Date FDA Received03/19/2020
Supplement Dates Manufacturer Received03/09/2020
Supplement Dates FDA Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
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