MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 195274

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint is related to (b)(4)/ medwatch #1828100-2018-00658.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the level sensing system was turned off when it started alarming, and would not turn back on.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: regarding the incident the perfusion team had with the level alarm (red) sensor cable on a cpb procedure on (b)(6) 2018.The system set up and had no issues prior to initiation of cpb.Shortly after initiation the team received a level disconnected message in the messaging area on the central control monitor (ccm).The level was appropriate in the venous reservoir, and the team re-gelled the sensor and twisted the sensor back in place.The alarm continued to occur, therefore they opted to turn off the level detection system.This incident did not delay the surgical procedure, and there was no blood loss or harm associated with the event.The team used this same level sensor on a previous procedure the day before, (b)(6) 2018.

Manufacturer Narrative

The reported complaint was not verifiable.Multiple diligence attempts for part return and additional information were unsuccessful therefore no evaluation was done.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8185785
• MDR Text Key: 131806719
• Report Number: 1828100-2018-00659
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 195274
• Device Catalogue Number: 195274
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1