• 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); Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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) via a device manufacturer representative regarding a patient receiving morphine(7. 5 mg/ml, 4. 7 mg/day), clonidine(600 mcg/ml, 376. 74 mcg/day) and bupivacaine(7. 5 mg/day, unknown concentration) via an implantable infusion pump. It was reported that there were multiple volume discrepancies of 5-6ml per refill. The pump was replaced on (b)(6) 2018. It was unknown if any environmental/external/patient factors may have led or contributed to the issue. It was unknown if the issue was resolved and patient status was alive with no injury. No further complication was reported.
 
Manufacturer Narrative
Product id: 8731sc, serial# (b)(4), product type: catheter. Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: (b)(4) 23, udi#: (b)(4). Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. The pump was returned, and analysis found catheter sc connector coring-tears-cuts in seal/meets leak criteria. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Pump was returned with no new information.
 
Manufacturer Narrative
Corrected information. If information is provided in the future, a supplemental report will be issued.
 
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 Key7476073
MDR Text Key106991215
Report Number3004209178-2018-09712
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,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2013
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: 05/01/2018 Patient Sequence Number: 1
-
-