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

Model Number	11827
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint number: (b)(4).Investigation results pending evaluation of the device.
Event or Problem Description
It was reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate.The pump was subsequently explanted.
Additional Manufacturer Narrative
Additional data: d4 (lot #) corrected data: b1, d4 (udi), g1.Device was returned for analysis.A visual inspection found that the bottom of the pump was flat and not curved outward.Additionally, there was a slight inward recess at the center of the pump can.After the pump has been freon filled and completed the manufacturing process, the bottom of a pump can mechanically deforms outward due to the internal freon pressure.A flat can indicates that a pump does not have any freon.Engineering identified weld discoloration (blue discoloration) where the outlet tube was welded to the can.A freon sniffer (leak detector) was used around the freon fill tube and could not measure a significant level of freon above the baseline in air value.This is a potential indicator that all the freon has leaked from the pump.A lack of pressure change indicates that the pump does not have any freon left.Continued analysis of the pump confirmed the pump was unable to prime or flow.This is considered an isolated incident.The issue will continue to be monitored for trending.A review of the dhr indicates that the pump passed all standard manufacturing flow testing.This indicates that the pump was sufficiently filled with freon and was working as intended through the standard manufacturing flow testing.Internal complaint number: complaint- (b)(4).

• Brand Name: PROMETRA PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 8579244
• Report Number: 3010079947-2019-00066
• Device Sequence Number: 1586692
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: 0100810335020082102004317170122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2017
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 20043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention