• 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 8637-20
Device Problems Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2017
Event Type  Injury  
Manufacturer Narrative
The pump was returned, and analysis found resistance in the battery. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. Eval code-conclusion 92 is no longer applicable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider on november 09, 2017. It was indicated the pump was replaced on (b)(6) 2017. The device was returned to the manufacturer for analysis on (b)(6) 2017. It was indicated the pump had been used with/in the patient for treatment. There was no patient death, and the patient recovered without sequela. It was reported the reason for the device removal was battery depletion. No rotor/dye studies had been performed. Per the device logs, the pump had been examined on (b)(6) 2017, with the last change occurring on (b)(6) 2017. The logs indicated the pump was in safe state, and a reset had occurred. The pump was delivering 1. 0 mg/ml of dilaudid at 0. 0061 mg/day in minimum rate infusion mode. The elective replacement indicator (eri) was 8 months. The logs indicated an "eri occurred" message on (b)(6) 2017 at 17:39, along with a "reset occurred," "reset occurred - low battery," and "pump in safe state" message at the same time.
 
Event Description
Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was receiving 1 mg/ml dilaudid at 0. 0480 mg/day via an implantable pump for an unknown indication for use. It was reported that the patient's pump started beeping on friday and she went into the clinic. The pump was read and "reset occurred" and "pump in safe state" messages were noted. There were no known environmental, external, or patient factors that may have led or contributed to the issue. No diagnostics or troubleshooting occurred. No actions or interventions were taken aside from replacing the pump and the event was considered to be resolved. The patient was noted to be "alive - no injury" and no symptoms were reported. No further issues 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 Key6961973
MDR Text Key102127994
Report Number3004209178-2017-22148
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2011
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: 10/19/2017 Patient Sequence Number: 1
-
-