MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)

Patient Problem Sedation (2368)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 8840, product type programmer, physician.Product id 8870, product type software.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient currently receiving clonidine (304.1 mcg/ml at 96.3 mcg/day), bupivacaine (23.8 mg/ml at 7.5 mg/day), ketamine (311.9mg/ml at 98.8 mg/day), and morphine (6.3 mg/ml at 2.0 mg/day) via an implanted pump.The pump had previously been delivering clonidine (243.3 mcg/ml at 108.5 mcg/day), bupivacaine (19 mg/ml at 8.47 mg/day), ketamine (249.5 mg/ml at 111.2 mg/day), and morphine (5 mg/ml at 2.23 mg/day).The indication for pump use was non-malignant pain.On (b)(6) 2018 it was reported that the drug concentration was changed; however, the change was never put into the programmer on (b)(6) 2018.The patient had been getting more drug (2.8 mg/day simple continuous mode) than intended as a result.The actual dose entered into the programmer was 2.23 mg/day.The patient was a little sedated as a result.The reservoir volume was changed.Via calculations it was confirmed that there was no old drug still in the system.The pump was going to programmed to the correct concentrations and the new dose per day would be 2.0 mg/day in simple continuous mode with boluses.No further complications were reported/anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7298697
• MDR Text Key: 101163575
• Report Number: 3004209178-2018-04021
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Date Device Manufactured: 06/26/2013
• 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 Age: 84 YR