MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-55112

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Code Available (3191)

Event Date 10/12/2020

Event Type  Injury  

Event Description

It was reported a second procedure was needed for catheter exchange.After fourteen hours of treatment, using an ekosonic kit 106cm 12cm tz for a bilateral pulmonary thromboendarterectomy (pte) case, a "no zones/groups enabled" alarm occurred.Troubleshooting efforts were attempted, but unsuccessful.The alarm returned when ekos was restarted.The physician decided to exchange the catheter due to the case complexity.Treatment was able to be completed successfully.

• Brand Name: EKOSONIC KIT 106CM 12CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• Manufacturer (Section G): EKOS CORPORATION; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10791309
• MDR Text Key: 214750088
• Report Number: 2134265-2020-15135
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 0191216014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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: 55 YR