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 Inaccurate Flow Rate (1249)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

The reported problem was discovered while giving a demonstration about the coast safety connection setting.As per the manufacturer's clinical specialist, the unit was restarted and was then functional.The unit operated to manufacturer's specification.

Event Description

It was reported that during the use of the device for a non-clinical activity, the centrifugal pump was set to coast at 1500 revolutions per minute (rpms), but during coast mode, the flow increased by itself.There was no patient involvement.

Manufacturer Narrative

The field service representative (fsr) was unable to verify the reported complaint.He replaced the occluder module occluder head, flow module with flow sensor as requested by the clinical specialist.The unit operated to the manufacturer's specifications.The suspect devices were returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst) observed the flow meter and flow sensor to fuction as intended throughout the evaluation.Per data log analysis, the incident actually occurred on (b)(6) 2018.15:04:36 art centrifugal pump started.15:06:31 art speed set to 1392 rpm (below coast).15:08:03 level alert with a coast response art speed remains the same as expected.15:08:29 level alert clears.15:09:24 art speed set to 2350 rpm.15:09:28 level alert with a coast response art speed goes to 1500 rpm (coast).15:09:47 level alert clears.15:10:05 to 15:10:37 art speed varied and ends at 1548 rpm (1550 is considered coast).15:13:11 art speed set to 2394 rpm.15:13:13 pressure alert with message only response.15:13:22 pressure alarm occurs and clears with coast response.Art speed was being adjusted when this occurred but still went to 1500 rpm as expected.15:13:50 art speed increased to 2070 rpm.15:14:04 air detected alarm with coast response art speed goes to 1500 rpm.15:14:16 art speed increased to 1806 rpm.15:14:23 air detected alarm cleared.15:15:19 art speed increased to 2200 rpm.There is no indication of a problem in the log.The centrifugal pump was running at 1500 revolutions per minute (rpm) until the speed was increased after each coast trigger.Since the setpoint was at 1500 rpm, an unexpected speed increase would have been reported as an overspeed but that did not occur.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
• MDR Report Key: 8023318
• MDR Text Key: 125637695
• Report Number: 1828100-2018-00567
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)180309
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816572
• Device Catalogue Number: 816572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 11/14/2018; 01/04/2019
• Supplement Dates FDA Received: 12/04/2018; 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1