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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 8637-20
Device Problems Filling Problem (1233); Failure To Service (1563); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Device Ingredient or Reagent Problem (2910); Activation Failure (3270)
Patient Problem Swelling (2091)
Event Date 02/25/2018
Event Type  malfunction  
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 dilaudid (15 mg/ml at 5 mg/day) via an implantable infusion pump. The patient had a medical history of chronic pain, chronic gastrointestinal problems, and was a chronic smoker. It was reported that the patient was noncompliant with refill protocols for an unknown reason and the pump had been alarming due to the pump being empty. During the refill appointment. 2ml were aspirated from the pump. It was reported that resistance was met and the hcp was only able to instill 15 ml into the 20 ml pump. The refill process was halted and using a fresh 20 ml syringe 15 ml of drug were aspirated and the tubing was clamped. The hcp attempted to remove any possible air from the pump reservoir. The pump was then reinjected with medication, the injection was noted as slow. It was reported that slight swelling appeared at the injection site and the reservoir was immediately accessed using a fresh refill kit. It was noted that 17 ml of drug were aspirated (3 ml were wasted during the refill process). It was reported that 4 ml of amber fluid were aspirated from the pocket site. The pump was placed into minimum rate and the patient was medically managed. Itwas noted that the patient had chronic falls due to their gastrointestinal problem. The patient was reported as alive with no injury. The issue was not resolved at the time of this report. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
The previous reported code of (b)(4) is now obsolete. The previous reported recall of z-1060-2011 is now obsolete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via device manufacturer representative indicated that the 4 ml of aspirated fluid was from an unknown source and was not a pocket fill. It was unknown when the missed refill and empty pump alarm was first noticed. Surgical intervention was likely but details were unknown. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a device manufacturer representative indicated that the following refill dates and alarms: refill on (b)(6) 2018 with alarm date of (b)(^) 2018, refill date on (b)(^) 2018 with an alarm date of (b)(6) 2018 (no show to appointment), and a rescheduled refill date of (b)(6) 2018 (no show to appointment). It was reported that the patient has a follow up appointment on (b)(6) 2018 to discuss a plan of care. No further information has been reported as a result of this event.
 
Manufacturer Narrative
The pump was returned and analysis found no significant anomalies. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7472112
MDR Text Key106863004
Report Number3004209178-2018-09562
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

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