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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Nonstandard Device (1420); Volume Accuracy Problem (1675)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/23/2018

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 professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 10 mcg/ml prialt at a dose of 0.577 mcg/day via an implantable infusion pump for non-malignant pain and chronic low back pain.It was reported that the patient had multiple volume discrepancies and the reservoir was accessed.On (b)(6) 2018 the expected residual volume (erv) was 16.4 ml and the actual residual volume (arv) was 8 ml.On (b)(6) 2018 the erv was 16.8 ml and the arv was 11 ml.It was unknown if the patient had any symptoms at this time.The rep did not think the pump logs were checked at this time.The rep was to meet with the hcp on (b)(6) 2018 and discuss further details.The rep stated from the telemetry strip he noticed they increased the patient's dose by 20% to 0.691 mcg/day on (b)(6) 2018.The rep was uncertain why they increased the dose since the volume discrepancy was leaning towards over infusion.The rep was to follow-up on this.No further complications were expected or anticipated.

Manufacturer Narrative

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

Event Description

On (b)(4) 2018, additional information was received from the hcp.It reported that the cause of the discrepancies was not determined.No further actions were taken because the patient passed away two days after the second discrepancy as a result of complications related to heart failure.

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: 7674324
• MDR Text Key: 114014164
• Report Number: 3004209178-2018-15420
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/20/2013
• 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-1570-2014
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 120