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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 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Fatigue (1849); Overdose (1988); Dizziness (2194); Toxicity (2333); Lethargy (2560)
Event Date 02/14/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) on (b)(6) 2019 regarding a patient receiving fentanyl (1000mcg/ml at an unknown dose) via an implanted infusion pump. The indication for use was non-malignant pain. It was reported that the patient may be experiencing a reaction to the medicine or the pump was malfunctioning, and the pump off code was requested. It was noted that (b)(6) (relative to the date of report) the patient began experiencing symptoms of lethargy, drowsiness, dizziness, and drunkenness. The patient went to the emergency department (ed) on the night of (b)(6) 2019, and on (b)(6) 2019 the hcp caught the patient from falling on the floor. The hcp started a narcan drip and contacted technical services. The pump was accessed and the expected reservoir volume and actual reservoir volume were correct, along with all programming including the bridge bolus (bb) with catheter volume as 0. 245ml. It was noted that the fentanyl had been in the pump for about 24 hours, and the hcp did not have access to the programming that was done on (b)(6) 2019. It was noted that they confirmed the correct concentration from the pharmacy that supplied the fentanyl, and later insisted on programming the pump to off state. At the time of report the pump was at minimum rate. No further complications were reported or 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 Key8350307
MDR Text Key136494281
Report Number3004209178-2019-03502
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received02/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/10/2013
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: 02/19/2019 Patient Sequence Number: 1
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