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

Model Number 801046

Device Problem Pumping Stopped (1503)

Patient Problem Injury (2348)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Per data log analysis, the logs were exported on (b)(6) 2017, two days after the date the problem occurred.The system log was overwritten, so only the centrifugal pump, air bubble detector (abd), and level logs were used for this log analysis.On (b)(6) 2017: 07:55:24 a perfusion screen is opened, 08:04:24 arterial centrifugal pump is started, 08:11:30 air detection is turned on, 12:16:59 arterial centrifugal pump is stopped, 12:17:00 air detection is turned off, 12:24:37 arterial centrifugal pump is started, 12:26:23 air detection is turned on, 13:06:48 air detection alarm causes the arterial pump to stop as configured, 13:07:28 air detection is turned off, 13:07:34 arterial centrifugal pump is started, 13:10:16 air detection is turned on, 14:11:36 arterial centrifugal pump is stopped, 14:11:38 air detection is turned off, 14:21:11 the perfusion screen is exited.Note that level module log indicates it was not connected to the heart lung machine (hlm) or used on (b)(6) 2017.There was no indication of a problem in the logs, the pump stopped because of a safety connection to the abd, and air was detected.Per the manufacturer's subsidiary, the user facility tried to turn the pump on with local controls by pressing the on and off button several times but the pump did not activate.After 15-20 seconds the pump started again and no problem occurred until the end of the procedure.The patient's blood volume was depleted in the pump reservoir causing the patient's blood pressure to drop to zero.The patient was reported to be hemiplegic and is not waking up.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was a rise in flow and then the pump stopped suddenly at about four liters of flow.As a result, an alternate device was employed.There was a delay of 15-20 seconds in the procedure.The surgical procedure was completed successfully.There was no blood loss.

Manufacturer Narrative

The cable from the base to the control unit and the pump motor was replaced.

Event Description

Per additional information obtained from the manufacturer's subsidiary, the patient is recovering slowly.The perfusion team was able to restart the flow as noted from the log data analysis along with pressing the on/off button and coming up on the rpms to the patient.The log data suggested that it was a safety intervention of the air bubble detector (abd) that stopped the pump.The pump was configured to stop during an active abd alarm.The clinician stated that they place their air bubble detector approximately 10 centimeters from the exit of the oxygenator.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed no unusual stoppage of the pump.The start/stop button on the centrifugal control module was not functioning.As seen by the data logs the stoppage of the pump was not from the switch rather the safety configuration and detection of air in the circuit.The user configured the device and it worked well with no issues.The cause of the pump stop was because air bubbles were found while debubbling the circuit as the configuration was set to respond.The device responded appropriately and as it was configured.It was determined that the user was unaware of the safety connection configurations.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

Per clinical review: according to the information the manufacturer has received, the original procedure was a coronary artery bypass procedure but the surgeon had to reinstate cardiopulmonary bypass (cpb) to replace the aortic valve.The team had completed the coronary artery bypass times two, and came off bypass.According to the log data, the centrifugal pump was started at 8:04:24, arterial bubble detector (abd) turned on at 8:11:30, pump stopped at 12:16:59 - indication of the first pump procedure.At 12:17:00 abd was turned off.At 12:24:37 arterial pump started and at 12:26:23 abd was turned back on.Start of the second pump/perfusion run.At 13:06:48 abd alarm stops the forward flow of the pump, and indicates stopped pump.The heart lung machine (hlm) at this hospital is set/configured to stop the pump when an air bubble is sensed by the abd.At 13:07:28 user turns off abd.At 13:07:34 user gets pump started again.At 13:10:16 clinician reengages abd to on.Also noted that at 14:11:36 pump is stopped and at 14:21:11 team exited out of perfusion screen.The 14:11:36 is the indication of coming off bypass on the second perfusion/pump run.Level detector was not used on this procedure.Clinician states that there was no alarm or alert message, and that the only thing that alerted him was an accumulation of volume in his reservoir.It is stated that the clinician was de-bubbling the cardioplegia (cpb) during the time this event occurred.The clinician stated they were not able to restart it by pressing the start button, but that after about 10-15 seconds, the rpm 0 appeared again and that they were able to start forward flow.The clinician has to reset or turn off the abd to enable forward flow when the pump is configured to stop on an active abd alarm occurrence.The log data shows the clinician turned off the abd, then started the centrifugal pump.The clinician waited approximately three minutes to reengage the abd.Questions regarding oxygenator product, activated clotting time (act) numbers along with act measuring device, patient coagulation abnormalities, circuit coagulation, line pressures on the bypass circuit were all asked.All these answers were within clinical norms.On (b)(6) 2017, 10:01, patient harm is reported, without further detail.On (b)(6) 2017, 03:24 confirmation patient is doing all right.On (b)(6) 2017 08:51, additional details added - in contradiction to earlier information thee manufacturer was informed that the patient is not doing well, hemiplegia is reported and the patient does not wake up.No further information is available on the state of the patient.The incident did not delay the surgical procedure; forward flow to the patient was stopped from 13:06:48 to 13:07:34, 46 seconds.There was no blood loss associated with the event, and the apparent harm is listed above.

Manufacturer Narrative

The reported complaint was confirmed.It was determined through analysis of the data logs that a safety connection was configured to the pump wherein it responded as it was set up to do.No part was returned to the manufacturer for evaluation.Multiple diligence attempts for part return were unsuccessful.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

Evaluation is in progress, but not yet concluded.

• 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
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7128521
• MDR Text Key: 95210776
• Report Number: 1828100-2017-00576
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801046
• Device Catalogue Number: 801046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2004
• 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
• Treatment: SORIN SYNTHESIS OXYGENATOR
• Patient Outcome(s): Life Threatening; Other