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

Model Number 8637-40

Device Problems Suction Problem (2170); Infusion or Flow Problem (2964)

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

Event Date 07/27/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, lot/serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: catheter, ubd: 17-feb-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a drug infusion device.The drug being delivered was morphine with an unknown dose and concentration.The reason for use was not reported.It was reported that the surgeon wanted to replace catheter during a pump replacement because he felt like it did not aspirate properly.The explant occurred on (b)(6) 2018.There were no patient signs or symptoms.The issue was resolved at the time of the report and the patient status was listed as ¿alive ¿ no injury¿.The customer was not notified that the product should be returned to the manufacturer and the catheter would not be returned as the customer discarded the product.There were no environmental/external/patient factors that may have led or contributed to the issue.No diagnostics/troubleshooting were performed.The patient weight was unknown.The healthcare professional would have no further information on the event for the manufacturer.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep on (b)(6) 2018.It was reported that it was unknown why the catheter did not aspirate.The pump had reached end of life and was replaced.The rep was present at the case so they reported it.There were no further complications reported/anticipated.

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: 7738886
• MDR Text Key: 115677570
• Report Number: 3004209178-2018-17123
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• 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: 08/08/2018
• Date Device Manufactured: 06/26/2012
• 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: 44 YR