MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP (40 ML) IMPLANTABLE INFUSION PUMP

Model Number 16827

Device Problems Short Fill (1575); Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Pending device return for evaluation. Follow-up is being conducted to gather further information regarding the alleged event. (b)(4).

Event Description

Sales representative reported a prometra ii 40 ml pump was explanted due to a volume discrepancy and allegedly not delivering medication. The sequence of events is as follows: (b)(6) 2020: pump is implanted. Nothing remarkable is reported about the implant procedure. (b)(6) 2020: catheter dye study is conducted for an unknown reason, in which the catheter was found to be patent. A volume check was conducted in which the following volume discrepancy was observed: expected volume: 16 mls; returned volume: 19 mls. (b)(6) 2020: the physician removed the medication from the reservoir and found that the returned volume was 19 mls. The physician proceeded with explanting the pump. A demand bolus was performed on the backtable, in which the drug was observed to deliver from the pump. The catheter is reported to be a flowonix catheter. No pump errors were reported. Any falls, traumas, or mris are unknown.

• Brand Name: PROMETRA II PROGRAMMABLE PUMP (40 ML)
• Type of Device: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive, nj
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, nj ; 4269229
• MDR Report Key: 9950024
• MDR Text Key: 187264468
• Report Number: 3010079947-2020-00229
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/22/2020
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 25936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/10/2020 Patient Sequence Number: 1