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

Model Number 91827

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Itching Sensation (1943); Cramp(s) (2193); Discomfort (2330); Inadequate Pain Relief (2388); Underdose (2542); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

Pending further follow-up information.(b)(4).

Event Description

Distributor reported, "irregular infusion with consequent crisis due to an iper or under drug dose and final infusion block and withdrawal symptoms." pump was explanted and replaced.

Event Description

Distributor reported, "irregular infusion with consequent crisis due to an iper or under drug dose and final infusion block and withdrawal symptoms." pump was explanted and replaced.During the follow up agent provided below additional following information: on (b)(6) 2020: patient visited first aid department for withdrawal symptoms and insufficient pain control, with itch and cramps.Patient began experiencing withdrawal symptom.(b)(6) 2020: patient experienced withdrawal symptoms.Following few days patient was sleepy.(b)(6) 2020: patient again experienced withdrawal symptoms and was sleepy for few days.(b)(6) 2020: patient's withdrawal symptom continued.During the pump refill, underinfusion was observed.Expected volume: 15 ml.Aspirated volume: 17ml.(b)(6) 2020: during the pump refill, underinfusion was noted.Expected volume: 16ml.Aspirated volume: 20ml.Morphine was administered to the patient subcutaneously through an elastomeric pump with resolution of withdrawal symptoms.(b)(6) 2020: patients pump was replaced.

Manufacturer Narrative

Product return was requested.Pending return of the explanted pump for further evaluation.Internal complaint # (b)(4).

Manufacturer Narrative

Additional information: 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 non-conformances, 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 20ml of sterile water for injection and allowing the reservoir's pressure to return the fluid into the syringe.The reservoir was filled and the cap was flushed with 5ml of swi.A demand bolus of 0.300mg with a 1.00mg/ml concentration over 16 minutes was programmed with a programmer.Fluid droplets were observed at the tip of the stem indicating proper priming of the pump.The pump was programmed with a 1.994 mg daily dose multi-rate flow test over a 24- hour time period at 37 degrees for one day.The dispensed volume was 0% of the expected.The catheter access port and suture ring were removed and the pump was decontaminated a second time.The "pull open/hold open" currents were measured and the results showed that the current required to pull open both the inlet and outlet valves exceeded the design specification for the valve.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).

• Brand Name: PROMETRA PROGRAMMABLE PUMP
• Type of Device: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL INC.; 500 international drive; suite 200; mount olive, nj
• MDR Report Key: 10115156
• MDR Text Key: 193672611
• Report Number: 3010079947-2020-00239
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020310
• UDI-Public: (01)00810335020310(11)170425(17)190425
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2019
• Device Model Number: 91827
• Device Catalogue Number: 91827
• Device Lot Number: 22954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention