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

Model Number 801763

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).As of (b)(6) 2016, the patient is still in icu.The hospital asked the local terumo fsr to check out this system-1 as a precaution.The fsr visited the user facility and gathered the data logs for further evaluation.He was unable to duplicate any problems with the system-1.The fsr cleaned dry blood from the air bubble detector.The unit operated to manufacturer specifications and was returned to clinical use.Per the data log review, most of the module/pump logs cover that date and there is no indication of a problem in those logs.The system log only goes back to (b)(6) 2016 due to the logging issue and does not cover the date in question.There is no indication of a problem with the system in the logs.No parts or device will be returned to the manufacturer for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

The customer called to have field service perform a system check on the perfusion system and capture data logs, no alleged deficiency.The issue occurred during use of the device for a cardiopulmonary bypass (cpb).The device was not changed out.The surgical procedure was completed as scheduled.There was no delay and no blood loss.Per the clinical review on 31-aug-2016: manufacturer clinical services (cs) spoke to the perfusionist (ccp) on the case in regards to this procedure and he provided these details.The actual surgical procedure was (b)(6) 2016.Though the procedure coronary artery bypass graft (cabg x3) was completed as scheduled and without known technical or clinical issues, the patient was "slow" to awake post surgery in the intensive care unit (icu).According to the ccp, a centrifugal pump was used as the arterial pump and he used all the available safety systems, including: an air bubble detector, level sensors, and line pressure monitoring.The ccp stated no active alarms occurred during the procedure and no air was ever observed in main sections of the cpb circuit.The ccp stated the venous oxygen saturation (svo2) was in normal range during cpb with no levels less than 72%.Cerebral oximetry was used and no issues were observed and cerebral oxygen saturations were adequate and at expected levels.The patient was weaned from cpb without issues and transferred to icu per normal practice.Neurologic dysfunction was observed later in the icu, but again there was no indication or mention of a malfunction of the system-1 and/or perfusion circuit.This system-1 was used multiple times after this procedure on (b)(6) 2016.This hospital had a patient injury event during cpb in (b)(6) 2014.As a system-1 (not this system) was used on that earlier procedure, and risk management became aware of this recent patient, the hospital asked the local field service representative (fsr) to check out this system-1 as a precaution.The manufacturer was informed of this incident on 26-aug- 2016.The system was inspected and no functional issues were found.The procedure on (b)(6) 2016 was completed as scheduled, with no delay and no associated blood loss.The patient did have a serious injury post surgery, but there is no indication of any malfunctions of the system-1.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5962726
• MDR Text Key: 55114654
• Report Number: 1828100-2016-00629
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention