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

Model Number 13827

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

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.Device was not returned for additional evaluation and investigation.As additional investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.Follow-up with the reported physician were unsuccessful and therefore, no additional information was able to be obtained.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

Event Description

It was reported that a patient's pump was explanted due to it malfunctioning.The pump was originally "working great", but then the patient began hearing "three beeps" and alleged that the battery on it was "going out.".

• 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 07828
• 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 07828 ; 9734269229
• MDR Report Key: 12350892
• MDR Text Key: 267624397
• Report Number: 3010079947-2021-00145
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)20651(17)160121
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2016
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 20651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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