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 Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the centrifugal control unit (ccu) had no forward flow.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The centrifugal motor that was part of the centrifugal system was: part number: 164267, serial number: (b)(4), udi: (b)(4).The field service representative (fsr) could not duplicate the reported complaint.The centrifugal system was tested and release testing was passed.The unit operated to the manufacturer's specifications.Per data log review: on (b)(6) 2022 the system was powered up at 07:05:41 am.A perfusion screen was opened at 07:06:13 am.The arterial pump was a centrifugal pump.The arterial pump was started and ran to 1482 revolutions per minute (rpm) at 07:11:23 am.At 07:12:11 am the arterial speed was increased to 1644 rpm.The speed was set to 1638 rpm at 07:32:38am.At 07:34:38 am the pump speed was set to 0 stopping the pump.At 07:39:45 am the pump was started again, the speed was set to 1572 rpm.At 11:40:45 am the speed was increased to 1926 rpm.At 11:50:45 am the speed was reduced to 0 stopping the pump.The pump was started/stopped/started and the speed was set to 1410 rpm at 11:51:04 am.The speed was set to 2370 rpm at 12:13:00 pm and a backflow alarm occurred.The speed was set to 2556 rpm and the backflow cleared at 12:13:19 pm.More backflow alarms occurred indicating issues with achieving forward flow as reported.The pump speed was set to 0 stopping the pump again at 12:14:03 pm.The arterial pump was started again and the speed was increased to 2106 rpm and then 2112 rpm at 12:15:14 pm.Everything looked normal in the log from here and the perfusion screen was exited at 2:06:30 pm.The log confirmed that there was difficulty achieving forward flow initially but did not indicate why.

Manufacturer Narrative

Updated.

Event Description

Per clinical review: on (b)(6) 2022, the team had a situation with their heart lung machine (hlm) while on cardiopulmonary bypass (cpb) whereby they were unable to achieve forward flow and were questioning the centrifugal control unit.There was no delay, no blood loss, and no adverse event reported.The complaint had stated that the device was changed out, but subsequently, the field service representative (fsr) found no problem with the device and no parts were returned.The manufacturer's clinical specialist contacted the user facility's biomedical engineer for clarification.The biomedical engineer was unaware of anything being changed out and that the normal centrifugal (electric) pump was not working and they transferred to the manual bypass.A fsr was then dispatched and found no issues.It is possible that certain lines were 'kinked' or 'pinched' which caused the non-flow of the device.Therefore, from this description, it appears that the clinician attempted to hand-crank in order to achieve forward flow, but possibly found a kinked line causing the problem.

Manufacturer Narrative

The reported complaint was confirmed.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 15074710
• MDR Text Key: 304624822
• Report Number: 1828100-2022-00268
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)211217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• 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): Required Intervention