• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Aspiration Issue (2883)
Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8731sc, serial#: (b)(4), implanted: 2(b)(6) 2014, product type: catheter. Product id: 8731sc, serial# : (b)(4) implanted: (b)(6), 2012, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: (b)(4), 2016 , udi#: (b)(4). Product id: 8731sc, serial/lot #(b)(4), ubd: (b)(4) 2013, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a company representative (rep) indicated the patient was having a ct scan since they could not clear the catheter for a dye study. It was reported the hcp had noted some volume discrepancies at refills so the hcp was going to do a side port access. The hcp could not aspirate the catheter and the hcp would like to fill the pump with saline and have the patient bolus to clear the drug from the system. The rep requested assistance in calculating how long it would take to clear the drug using the ptm. It was clarified the hcp would like to do a dye study on monday, (b)(6) 2018 once the catheter was cleared. Technical services reviewed the hcp could fill the pump on saturday and it would be cleared by monday. The rep was to follow up with the hcp. The reporter would review the hours to clear calculation as well as the concerns about potential for overdose if the catheter was not completely cleared. Patient symptoms were not reported. The event date was (b)(6) 2018. The rep called back and stated the plan was to bring the patient in on monday ((b)(6) 2018) and put saline in the pump. It was asked how long it would take to clear the pump tubing and catheter of drug after filling with saline assuming the patient used all available boluses. It was reviewed the drug would last less than 1 day if the patient were to use all available boluses (patient could take 2x/3 hours and 12x/day). No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving fentanyl: 25. 0 mcg/ml, 4. 502 mcg/day; bupivacaine 16. 0 mcg/ml, 2. 881 mcg/day; and clonidine 1000. 0 mg/ml, 180. 1 mcg/day via an implantable pump for spinal pain. It was reported the patient thought they would be having a computerized tomography (cat) scan or their healthcare provider (hcp) would ¿shoot dye into the pump. ¿ the patient noted that his head was ¿being arthedic. ¿ the patient also reported they were not getting all of their medication. The patient stated they had a refill appointment with their healthcare provider that day ((b)(6) 2018) and there was supposed to be ¿4. 7 mg¿ of medicine left in the pump, but there was 12. However, the patient also said there was supposed to be ¿3 mg,¿ but there was ¿11 or 12. ¿ the patient stated this issue had been happening every time they saw their healthcare provider. The patient gets refilled every month and a half (5-6 weeks). It was unknown when the issue first began. The patient confirmed they were working with their healthcare provider to determine the reason for the issue. The patient also reported they had to travel a long distance to their healthcare provider via a bus and ferry. The patient stated when they got to their healthcare provider¿s office that day ((b)(6) 2018) their blood pressure was 193/116. The patient also reported they could not sleep because of the pain. When asked when the issue began, the patient said the issue began when they were injured, and noted they had a sleep therapy done. The patient stated they did not have sleep apnea, and they did not get rem sleep. No out of box problems were reported. No medical or therapy problems associated with a small part were reported. The patient was directed to follow-up with their healthcare provider regarding the volume discrepancy issue and symptoms reported. No further complications were reported or anticipated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7441628
MDR Text Key106185917
Report Number3004209178-2018-08352
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/20/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-