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

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 7472112
• MDR Text Key: 106863004
• Report Number: 3004209178-2018-09562
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• 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 Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1060-2011