MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 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 Death (1802)

Event Date 01/31/2019

Event Type  Death  

Manufacturer Narrative

The field service representative (fsr) verified that the hlm operated as intended and to the manufacturer's specifications.Per data log analysis, there were four large roller pumps used in this configuration, epgs, level sensor, pressure sensor, two temperature sensors and no air bubble detector (abd).Lv vent - level alarm alert message only, pressure alarm alert message only.Cpg - level alarm stop pump, level alert message only, pressure alarm pauses, pressure alert message only.Vent - no safety linked to this pump.Sucker1 - no safety linked to this pump.On (b)(6) "1019": 8:18:51 am system power up; 8:20:23 am load perfusion screen; 8:20:23am alert and alarm probe selected; 8:20:35 start case; the level was not enable during this case until the end of the case at 4:25:28 pm; 4:26:59pm shutdown.On (b)(6) "1019": 9:22:17pm system power up; 9:31:08 load perfusion screen; 9:31:21 pm start case; 9:31:44pm alert alarm probe selected; 9:31:48pm enable alert alarm; 9:32:33pm alert probe selected; 8:32:18pm alert alarm disabled; 9:35:48pm alert alarm enabled; 9:35:55pm alert alarm disabled; 9:36:36pm end case.In conclusion, the level alert/alarm was disabled between 8:18:51 am until the system shutdown at 4:26:59pm.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, air had entered the circuit and was delivered to the patient.As a result, an alternate device was employed.Per clinical review: the system the team uses consists of a heart lung machine (hlm) base, two vent pumps, a sucker pump and a cardioplegia (cpg) pump.Their arterial primary pump is a medtronic centrifugal pump, and the disposables they use on their procedures are manufactured by medtronic as well as their oxygenator, centrifugal pump and tubing sets.The pump is configured with the electronic patient gas system (epgs), level detection system, pressure system and a temperature module.The team does not use the air detection system available with the hlm.The information available from the perfusionist is that during a cpb on (b)(6) 2019, the arterial disposable circuitry had air that was in turn delivered to the patient.The patient expired two days later.The perfusionist asked the manufacturer of the base to evaluate the log data on the system.He stated that he had spoken with medtronic and did his due diligence with that manufacturer for the arterial pump hardware along with the disposables.He did state that he only uses the base, epgs and roller pumps, and that the data from the log analysis will state all worked to specifications.The patient had the circuitry and oxygenator exchanged on bypass, which correlates to the blood loss stated by the institution of approximately 2000 milliliters.The blood loss is associated with the use of the medtronic disposables.The delay of approximately five minutes was due to exchanging the medtronic disposables.The perfusionist stated that he could not give any additional information regarding the case.

Manufacturer Narrative

The reported complaint was confirmed.The equipment used in this procedure was another manufacturer's arterial pump and disposable.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: 8367850
• MDR Text Key: 137074167
• Report Number: 1828100-2019-00088
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)180314
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• 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: 04/26/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC CENTRIFUGAL ARTERIAL PUMP; MEDTRONIC DISPOSABLE TUBING PACK; MEDTRONIC OXYGENATOR; MEDTRONIC CENTRIFUGAL ARTERIAL PUMP; MEDTRONIC DISPOSABLE TUBING PACK; MEDTRONIC OXYGENATOR
• Patient Outcome(s): Death