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

Model Number 13827

Device Problems Pumping Stopped (1503); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Pending device return for evaluation.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.

Event Description

On (b)(6) 2019, home infusion nurse reported a prometra ii pump with error codes 100 and 102 (adc test failed low).Patient allegedly heard the pump beeping earlier the same day.Troubleshooting attempts include: 1.Programming an emergency pump stop.2.Reprogramming the daily dose (successful).Programming the soft reset was successful; however, on (b)(6) 2020, error codes reappeared and patient began hearing beeping again.The following was performed: 1.Pump inquiry - error codes 100 and 102 displayed, 2.E-pump stop, 3.Reprogrammed the constant flow daily dose, 4.Pump inquiry - no error codes displayed.On (b)(6) 2020, clinical representative reported that the error codes returned and were reset again.On (b)(6) 2020, it was reported that the pump would be explanted and replaced on (b)(6) 2020.

Manufacturer Narrative

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, but a root cause for the alleged issue could not be confirmed.A visual inspection of the exterior of the pump did not show any anomalies.An inquiry of the pump confirmed the pump had error code 100: pump is in critical error, and error code 102: the acd test failed low.The pump is shut down, confirming the complaint.A soft reset was performed on the pump, successfully clearing the error codes.The pump was programmed and run for several days.Functional analysis of the pump confirmed the pump successfully primed and flowed within specification.The unit flowed at 90% efficiency.An inquiry was performed after three weeks and no error codes were observed.Please note that the device was able to function per specifications after it was reset at the customer site.As the device functioned per specification during the investigation, no definitive root cause could be determined for the alleged issue.Internal complaint number: (b)(4).

• 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: 10025160
• MDR Text Key: 194318835
• Report Number: 3010079947-2020-00233
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)24940(17)190614
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/14/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention