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

Model Number 816572

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) could not verify the reported centrifugal flow problems.The centrifugal pump system and flow monitor functioned properly when tested.He reseated all centrifugal pump and flow monitoring connections, and cleaned the centrifugal flow sensor.The pump and flow monitoring calibrations and operations were checked.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal control unit displayed a flow reading of about 200 milliliters (ml) with the appearance of minimal forward flow.The surgical procedure was completed successfully.There was a six minute delay.Several ml of blood were drained into the venous reservoir during initial discontinuation of cpb which was returned to the patient.There was no adverse consequences to the patient.Per clinical review: the manufacturer's clinical specialist spoke with the facility's perfusionist regarding the incident the team had during a cpb procedure on (b)(6) 2020.The team set up and had been recirculating with prime prior to going on bypass.Upon initiation of cpb, the perfusionist saw on the centrifugal pump display a flow reading of 200 ml/minute and blood was being observed in the oxygenator/reservoir.There was no alarm situation and physiologically the patient was exhibiting a very high arterial pressure.Patient lines were clamped and cpb was discontinued.Perfusion assistance was called to the room.Hand crank was put into use and forward flow still could not be established.The battery back up was put into use and simultaneously a clamp was discovered on the arterial line.The clamp was removed and bypass was reestablished.Once bypass was reestablished, there was no other issue for the remainder of the case.Due to the unexplained blood in the oxygenator and the inability to determine at what point this unobserved clamp was applied (and where), problems with the centrifugal pump could not be ruled out.Both units had preventative maintenance (pm) performed on them a few days prior ((b)(6) 2020-(b)(6) 2020).The perfusionist was asked to have the pump looked at and would like a letter of what the manufacturer found upon investigation, but stated there was a clamp on the arterial line preventing forward flow.There was a delay of six minutes.Several mls of patient blood drained to the venous reservoir during discontinuation of bypass which was returned to the patient.

Manufacturer Narrative

Corrected blocks: b1 and b2.From the previously submitted medwatch, please disregard the 'adverse event' checked box in b1 and the 'required intervention to prevent permanent impairment/damage (devices)' checked box in b2.After further discussion with the manufacturer's clinical specialist, it was determined that this complaint not be considered an adverse event nor required intervention to prevent permanent impairment/damage.

Manufacturer Narrative

Per data log analysis, on 04-dec-2020 a perfusion screen was opened at 06:32:38.06:32:55 arterial centrifugal is started, speed was increased, one backflow occurred 06:33:48 speed was increased and decreased to 0 stopping the pump 06:33:52 arterial centrifugal was started, speed was increased to 1926 revolutions per minute (rpm) 09:04:10 speed was adjusted up to 1992 rpm 09:07:17 speed was set to 1728 rpm 09:19:53 speed was adjusted down and then up to 2610 rpm 09:24:24 speed was set to 2406 rpm 09:29:02 speed was set to 2346 rpm 09:30:35 speed was set to 2394 rpm 09:33:49 speed was set to 2340 rpm 09:38:12 speed was set to 2280 rpm 09:42:27 speed was set to 2268 rpm slight speed adjustments continue until 10:32:23 when speed was set to 2484 rpm.At 12:35:12 the perfusion screen was exited stopping the arterial pump.There is no indication of a problem with the arterial centrifugal pump in the log.

Manufacturer Narrative

The reported complaint was not confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

After further review of the complaint details, this complaint was determined to require intervention to prevent permanent impairment/damage.

• 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: 11058665
• MDR Text Key: 224411263
• Report Number: 1828100-2020-00497
• Device Sequence Number: 1
• Product Code: DTQ
• 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,Followup,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816572
• Device Catalogue Number: 816572
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYGENATOR; VENOUS RESERVOIR
• Patient Outcome(s): Required Intervention