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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Device Displays Incorrect Message (2591); Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving bupivacaine, 10 mg/ml concentration at 3.3 mg/day dose, ketamine 150 mcg/ml concentration at 50 mcg/day dose and morphine, 30 mg/ml concentration at 10 mg/day dose via intrathecal drug delivery pump for non-malignant pain.It was reported that a pump alarm due to elective replacement indicator (eri) occurred, the alarm was heard/ confirmed by telemetry.Patient's last refill was on (b)(6) 2017 and at that time it showed patient still had 32 months left until eri.The hcp stated that the patient came in on this report date and the logs were showing that eri had already occurred and to replace the pump by (b)(6) 2017.The hcp confirmed that low reservoir alarm and eri alarm were occurring.Eri alarm was not expected.Low reservoir alarm was expected.Technical service specialist (tss) reviewed that pump had reached eri prematurely and they would need to replace the pump before end of service (eos) occurred.They had the patient scheduled for a replacement 4 days after this report date.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from healthcare professional on 2017-oct-03 reported the cause of the elective replacement indicator (eri) was unknown.The patient came in for a refill on (b)(6) 2017 and they saw a eri code when reading the pump.It was noted that the pump alarm/eric was resolved as the pump was replaced on (b)(6) 2017.The patient's weight at time of event was (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from manufacturer representative (rep) reported they were replacing the pump today ((b)(6) 2017) and would like to confirm programming information.It was noted the healthcare professional (hcp) was not able to aspirate, but the hcp did not feel it was an issue with the catheter, so they did not replace any part of the catheter.New pump information was provided.Catheter volume was 0.4ml, and back table prime was 0.2ml over 13 minutes (hcp was in a rush so they wanted to only wait 13 minutes).The old drug was taken from the old pump and placed into the new pump.The dose of the morphine dropped to 8mg/day.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from manufacturer representative (rep) on 2017-sep-29 reported the reason for elective replacement indicator (eri) was not determined.It was not determined why the catheter could not be aspirated.The healthcare professional (hcp) was confident it was still delivering medication.The patient did not miss a refill date.The patient had a refill in september, at which it was recognized they had an eri/ eri occurred.The pump was replaced and the alarm issue has been resolved.The patient's weight was unknown.The old pump was disposed of on the date of replacement, and it will not be sent back.No further complications were reported/anticipated.

• 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: 6900760
• MDR Text Key: 87633446
• Report Number: 3004209178-2017-20234
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Date Device Manufactured: 03/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 59