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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7298697
MDR Text Key101163575
Report Number3004209178-2018-04021
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/26/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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