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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Overfill (2404)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/02/2011

Event Type  malfunction  

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 consumer and healthcare professional (hcp) via a company representative regarding a patient receiving bupivacaine (33.6 mg/ml at 24.34 mg/day) and dilaudid (13.6 mg/ml at 9.85 mg/day) via an implanted pump.The indication for pump use was malignant pain and other pain indications.On (b)(6) 2017 it was reported that since implant the pump had had volume discrepancies where the actual residual volume was greater than the expected residual volume and the patient had been receiving ineffective therapy which had gradually been more noticeable for the last year.The patient felt that the pump wasn't delivering the therapy effectively.The therapy worked for a while and then for approximately 4 days it didn't work.It was a cyclical pattern of the therapy working and then waning.The hcp confirmed that they always got more back than expected.They saw 3-4 ml more than expected, but the hcp did not have the details.The pump logs were checked and nothing was found in the logs to attribute the issue to.A dye study was done a couple of years ago, but yielded nothing; no issues were found.The drug in the pump had remained the same over the life of the pump.The hcp had just increased the dose as the patient weaned off her oral meds.The pump was showing 13 months to eri (elective replacement indicator) so the hcp was unsure if the insurance company would allow him to replace the pump.No further patient complications have been reported as a result of this event.

Event Description

Additional information was received and it was reported that the pump was acting within normal tolerances.The pump showed no error or any reason for concern.The plan of action was to check the pump volume at the next refill to confirm the drug volume removed from the pump was within the expected range.The next pump refill was scheduled for (b)(6) 2017.

Event Description

Additional information was received on 30-jun-2017 and it was reported that they were still having issues with the pump underinfusing a little bit, but it was still within specifications.During the refill today, the hcp (healthcare professional) ordered 42 ml thinking the filter and tube of the refill kit would have them lose 1 ml.The hcp was thinking that he refilled the pump with 41 ml but programmed the pump to 40 ml.The hcp felt that this would help with the slight underinfusion they had been seeing.

Manufacturer Narrative

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: 6515352
• MDR Text Key: 73511773
• Report Number: 3004209178-2017-08876
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Date Device Manufactured: 09/21/2011
• 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 Age: 35 YR