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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 Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2018
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 21-sep-2014, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient receiving morphine (unknown form) 50mg/ml at 22. 49mg/day, fentanyl 600mcg/ml at 269. 90 mcg/day, bupivacaine 7. 5mg/ml at 3. 37 mg/day, and ketamine 4. 0mg/ml at 1. 799 mg/day flex dose via an implantable pump. The indications for use were non-malignant pain and failed back syndrome-other. On (b)(6) 2018 it was reported that per the healthcare provider at the refill on (b)(6) 2018, 27ml¿s were removed from the reservoir and 5. 7ml¿s were expected. On (b)(6) 2018 at the refill 20ml¿s was removed and 4. 8ml¿s were expected. At the time of the replacement intra-op 10ml¿s was removed and 2ml¿s were expected. The patient did not mention any change in pain level. It was unknown it there were any environmental, external or patient factors that may have led or contributed to the issue. The catheter was replaced and intra-op it was found that there was a black unknown substance at the tip of the catheter. The pump was also replaced at the time of the catheter replacement due to eri (elective replacement indicator). Following replacement post-op the pump was used to deliver infumorph 25 mg/ml at 10mg/day. The issue was resolved at the time of the event and it was noted that the healthcare provider would not have any further information regarding the event. The patient status was noted as alive, no injury and no further complications were reported.
 
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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 Key7600274
MDR Text Key111000630
Report Number3004209178-2018-13390
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 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2014
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 Received06/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/25/2012
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: 06/14/2018 Patient Sequence Number: 1
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