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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); Increase in Pressure (1491); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer's representative regarding a patient receiving compounded baclofen (50 mcg/ml at 35 mcg/day), morphine (15 mg/ml at 10 mg/day), fentanyl (8500 mcg/ml at 6049 mcg/day), bupivacaine (30 mg/ml at 21 mg/day), and dilaudid (15 mg/ml at 10 mg/day) via an implanted pump. The indication for use was non-malignant pain. It was reported there was a volume discrepancy at replacement and the pump was concaved posteriorly on (b)(6) 2019. When the pump was heated with hot water upon cleaning for return, the pump popped back out. Repeated several times before sending pump back. It was noted the patient had been scuba diving up to 100 feet. The patient heard the pump collapse/get pushed when diving and feels/hears it pop back out. This current pump¿s drug was aspirated <(>&<)> transferred to new pump on back table. The expected volume was 19. 6 ml, actual volume aspirated 15 ml. Not sure scrub tech aspirated fully. There were no diagnostics or troubleshooting performed. The pump was replaced for end of service and the issue resolved. The pump was to be sent back to the manufacture. The patient's weight was (b)(6).
 
Manufacturer Narrative
The pump was returned, and analysis found a stall due to shaft-bearing and corrosion and-or wear and-or lubrication. The pump exterior was concave. The catheter was returned, and analysis found coring-tears-cuts in seal of the sc connector. If information is provided in the future, a supplemental report will be issued.
 
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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 Key9281602
MDR Text Key178331840
Report Number3004209178-2019-21091
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,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2011
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: 11/05/2019 Patient Sequence Number: 1
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