MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULAR PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM

Model Number 6379

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the unit would not read any flow.No other details regarding the nature of this event were provided.

Event Description

Additional information received indicated that the reported complaint occurred prior to use of the device for a cardiopulmonary bypass (cpb) procedure.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

(b)(4).Per the user facility's perfusionist, he primed the heart-lung circuit and was circulating at approximately 4.2 liters per minute (l/min).He could visualize forward flow but the flow was reading "0.00".He checked for kinks, occlusions and opened the recirculation line.At this time, he repositioned the flow probe but that did not resolve the issue.He powered down the unit, counted to ten, restarted the pump and could visualize flow but was still getting a flow reading of "0.00".He replaced the flow probe but the problem remained.With a third flow probe he had the same results.

Event Description

Per clinical review: during set up and prime for a procedure on (b)(6) 2018, the perfusionist had problems with his pump.He had primed his cardiopulmonary bypass (cpb) circuit with his normal procedure.He was circulating at approximately 4.2 liters per minute (l/min).Per his practice, he keeps the pump circulating to enable any residual bubbles to purge from the cpb circuit.He left the room for a period of time and when he returned, his flow probe was reading 0.00 l/min, but the pump was rotating.He proceeded to check his circuit for any occlusion or kinks, finding none, he decided to open his recirculation line.He had forward flow, but the pump was sill reading 0.00 l/min.He checked the flow probe for positioning and repositioned it in a different area.This maneuver did not change the reading on the pump, it remained 0.00.He checked all connections to see if they were tight.He turned the pump off, waited ten seconds and turned it back on, this maneuver did not mitigate the problem either.He turned the pump off, replaced the flow probe, restarted the machine, generated flow, and the flow probe still read 0.00 l/min.He switch with a third flow probe, and no changes in the output, the pump was still reading 0.00 l/min with the third flow probe.The perfusionist opted to exchange the entire pump with a second pump, using the initial flow probe.This replacement enabled flow to be read accordingly.This incident did not delay the surgical procedure, for it was during priming of the circuit.There was no blood loss or harm associated with the event.

Manufacturer Narrative

The reported complaint was confirmed through information obtained by the manufacturer's clinical specialist.The field service representative (fsr) was unable to verify the reported complaint.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: SARNS 8000 MODULAR PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7241215
• MDR Text Key: 99289151
• Report Number: 1828100-2018-00058
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K915183
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SORIN S5