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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 Problem Pumping Stopped (1503)
Patient Problems Fall (1848); Pain (1994)
Event Date 09/20/2017
Event Type  Injury  
Manufacturer Narrative
Analysis of the pump revealed motor gear train anomalies. These included corrosion and/or wear and/or lubrication and stall due to shaft-bearing. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative. It was reported that the drug pump was replaced on friday, (b)(6) 2017. It was reported that the pump was replaced with serial number (b)(4). No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. Eval code-conclusion: code 92 no longer applies to this event. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4) no longer applies to this event. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine 5. 2 mg/ml at 2. 1984 mg/day and bupivacaine 4. 1 mg/ml at 1. 7333 mg/day via an implantable pump with simple continuous dosing for and unknown indication for use. It was reported that during normal use, the patient had stated they thought their drug pump alarm was going off and had also complained of increasing pain more than normal. It was reported that factors that may have led to or contributed to the issue were that the staff had said that there has been some history of falls, but there was no exact recording of these occurrences. It was reported that they interrogated the pump and it was found to be in a motor stall. The history on the logs show that it had been going in and out of motor stall since (b)(6) 2017. The pump logs were reviewed and indicated there were multiple motor stalls and recoveries that began on (b)(6) 2017 at 03:38 with the last motor stall occurring in the logs on (b)(6) 2017 at 14:19. There were also multiple ¿stopped pump period may exceed tube set¿ error messages on (b)(6) 2017 at 03:38, (b)(6) 2017 at 17:59, and (b)(6) 2017 at 07:36. It was reported that the patient has had their pump flow reduced to minimum rate and will be given alternative pain relief until a plan of action is determined. It was reported that the issues were not resolved at the time of this report. It was reported that no surgical intervention had occurred and it was asked, but unknown if any surgical intervention was planned. The patient status at the time of the report was alive ¿ no injury. No further complications were reported and/or anticipated.
 
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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 Key6947960
MDR Text Key101638990
Report Number3004209178-2017-21766
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
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