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 Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's technical support specialist, everything except the occluder module is connected on the right-hand side of the network interface card (nic).The two cables that went to the right side nic board were replaced and this corrected the problem.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) showed red "x"s and was continuously alarming.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2018, the heart-lung machine (hlm) was powered up without issue for a procedure that day.The perfusionist set up and primed the system without issue, initiating bypass shortly thereafter.Approximately 30 minutes into the cpb, the perfusionist received multiple red "x"s over modules.These modules included temperatures, level detection, pressures, air bubble detector (abd), electronic patient gas system (epgs) along with the left ventricle (lv) vent roller pump.The sucker roller pump had a "?" mark on its location on the ccm.The team lost their temperature reading, their pressure readings, the use of the epgs, use of abd, use of lv vent roller pump, intermittent use of the sucker pump, and use of the level detection system.The system was alarming with audible and visual alarms.The external flow meter from the epgs was bouncing up and down and their independent perfusion charting system was giving them a fraction of inspired oxygen (fio2) alarm of less than.3 (30%).The perfusionists did many mitigations to enable the system to function as needed.They were able to use the sucker pump using local controls.The perfusion team retrieved an independent level detector to monitor the volume level in the venous reservoir.The team also used separate pressure monitors to enable a pressure reading on their disposable circuit.The team went to a stand-alone oxygen (o2) tank to give o2 to the oxygenator the remainder of the procedure.Lastly, they used a hand crank intermittently on their vent pump when the vent was needed to be used.There was no delay in the surgical procedure.There was no apparent harm related to the issues related to the event.There was no blood loss.

Manufacturer Narrative

The reported complaint was confirmed.The retuned parts could not duplicate the confirmed event but removal and re-connectivity of the connections may have contributed to this reported issue.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

During laboratory analysis, the product surveillance technician (pst) observed the power cable assembly and the cable assembly to the network interface card (nic) on the right side of the pump to function as intended throughout the evaluation.Per data log analysis, on (b)(6) 2018 the system log shows multiple modules and pumps getting alarms and sometimes rebooting.The pump and module logs were not provided so the cause of the alarms could not be confirmed.Most likely the 5v supply was low, normally caused by the network interface card (nic) power cable from the power manager.

• 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: 8125708
• MDR Text Key: 129455889
• Report Number: 1828100-2018-00616
• 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
• Report Date: 01/27/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/11/2018; 01/18/2019
• Supplement Dates FDA Received: 01/04/2019; 01/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-03/27/12-006-C
• Patient Sequence Number: 1
• Treatment: EXTERNAL FLOW METER; INDEPENDENT LEVEL DETECTOR; OXYGEN TANK; OXYGENATOR
• Patient Outcome(s): Required Intervention