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

Model Number 13827

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint # - (b)(4).Device was returned for evaluation.Upon analysis, the pump primed and flowed within specification.No issue was found with the pump.A review of the dhr did not identify any nonconformances, issues or capas associated with pump function.Pending further follow-up for explant date and additional device information.

Event Description

Agent reported a prometra ii pump with volume discrepancies.The sequence of events is as follows: (b)(6) 2019: patient reported to be seen for a refill appointment.Patient reports that their pain level is severe and worsening.The patient reports no new injury or incident.The following volume discrepancy was observed: expected volume: 4.5 mls.Returned volume: 6 mls.(b)(6) 2019: patient reports for a refill.Patient reports pain as moderate-severe and worsening.The following volume discrepancy was observed: expected volume:4.87 mls.Returned volume: 18 mls.(b)(6) 2019: patient reports for a cap study.It was reported a 20g huber needle was used to access the catheter access port, in which 1 ml of clear fluid was removed.The dye was then reported to be inserted, which showed the catheter was patent and did not show any signs of kinks, occlusions, or leaks.The pump was reported to be programmed for a catheter priming bolus over 5 minutes.It is reported that the patient's catheter contains both flowonix and medtronic segments.While the refill kits used are unknown for the refill appointments, it was reported in each appointment that a 22g huber needle was used to access the pump.The programmer used to program the patient was reported to be v1.04.10.It is unknown if the patient uses a ptc and if the patient has had any mris.Pump was explanted on an unknown date.

Manufacturer Narrative

Root cause for the alleged volume discrepancy could not be confirmed.A supplemental mdr will be submitted if/when any additional information is received.Internal complaint #: (b)(4).

Event Description

Agent reported a prometra ii pump with volume discrepancies.The sequence of events is as follows: 1.(b)(6) 2019: patient reported to be seen for a refill appointment.Patient reports that their pain level is severe and worsening.The patient reports no new injury or incident.The following volume discrepancy was observed: expected volume: 4.5 mls; returned volume: 6 mls.2.(b)(6) 2019: patient reports for a refill.Patient reports pain as moderate-severe and worsening.The following volume discrepancy was observed: expected volume:4.87 mls returned volume: 18 mls.3.(b)(6) 2019: patient reports for a cap study.It was reported a 20g huber needle was used to access the catheter access port, in which 1 ml of clear fluid was removed.The dye was then reported to be inserted, which showed the catheter was patent and did not show any signs of kinks, occlusions, or leaks.The pump was reported to be programmed for a catheter priming bolus over 5 minutes.It is reported that the patient's catheter contains both flowonix and medtronic segments.While the refill kits used are unknown for the refill appointments, it was reported in each appointment that a 22g huber needle was used to access the pump.The programmer used to program the patient was reported to be v1.04.10.It is unknown if the patient uses a ptc and if the patient has had any mris.Pump was explanted and replaced.

• 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 Key: 9976776
• MDR Text Key: 191867995
• Report Number: 3010079947-2020-00231
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2016
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 20894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention