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

Model Number 91827

Device Problem Occlusion Within Device (1423)

Patient Problem Missing Value Reason (3192)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number: complaint- (b)(4).

Event Description

A health care professional reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate on a multiple occasions.On (b)(6) 2017, the pump and catheter were examined to determine functionality.The pump appeared to function properly and the catheter appeared to be occluded.The physician made the decision to explant and replace the pump.A new catheter was also implanted but the old catheter was tied and remains in the patient.

Manufacturer Narrative

Device evaluation: the returned pump underwent a series of investigative assessments to verify the reported issue including pathway priming and flow testing.Based on the results of the investigation, the reported issue was confirmed.The cause of the confirmed failure was undetermined as the valves worked per specification.Although the cause could not be determined, it is probable that it could be related to an obstruction in the flow path related to drug or drug precipitant, which may have cleared during investigation/destructive testing.(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 07828
• Manufacturer Contact: karen matis ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 7271320
• MDR Text Key: 100090445
• Report Number: 3010079947-2018-00028
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: Physician
• Device Expiration Date: 07/31/2016
• Device Model Number: 91827
• Device Catalogue Number: 91827
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention