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

Model Number 6382

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's perfusionist, the alarming occurred on a primed circuit but once forward flow was initiated the alarming stopped.This has occurred multiple times over the last two to three weeks.The field service representative (fsr) was unable to duplicate the reported complaint.He replaced the flow sensor as a precaution.The suspect device will be returned to the manufacturer for further evaluation.

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor was alarming and a "back flow" error message was displayed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) was unable to duplicate the reported complaint.The flow sensor functioned as intended throughout the evaluation.Per log analysis on (b)(6) 2018, the flow log does show many backflow alarms on (b)(6) 2018.There is no way to tell from the log if there was actual backflow occurring.There are other dates in the log that also show backflow alarms ((b)(6) 2018, (b)(6) 2018, and (b)(6) 2018).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: 7597669
• MDR Text Key: 111004558
• Report Number: 1828100-2018-00303
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000083
• UDI-Public: (01)00886799000083(11)171017
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1