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); Insufficient Flow or Under Infusion (2182); Intermittent Infusion (2341)

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

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving morphine (3.0 mg/ml at 1.3851 mg/day) and bupivacaine (15.0 mg/ml at 6.925 mg/day) via an implantable infusion pump.It was reported that at a refill on (b)(6) 2018 a critical alarm was heard coming from the pump.The pump was interrogated and the logs showed multiple stalls and restarts since (b)(6) 2018.During the refill the expected residual volume was 7ml and the actual residual volume was 17ml.The pump's elective replacement indicator (eri) was 9 months.Pump replacement was scheduled for (b)(6) 2018.It was noted as a potential factor that may have led or contributed to the issue that about a year ago the pump had run empty (see manufacturer report # 3004209178-2017-02509) but that the pump "seemed to be working ok after that time." 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 was received from the healthcare professional via manufacturer representative.It was reported that the device was replaced on (b)(6) 2018 and was returned to the manufacturer for analysis.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable infusion pump (b)(4) found a motor stall due to wear and/or corrosion and/or lubrication and a stall due to shaft bearing.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: 7361878
• MDR Text Key: 103179304
• Report Number: 3004209178-2018-05535
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR