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

Model Number 801188

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) was unable to verify that the epgs would not calibrate but did hear that the stepper motor was loud and kept adjusting.He replaced the epgs.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) would not always calibrate and had a clicking sound.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 reported complaint was confirmed.The service repair technician (srt) was unable to verify the reported complaint.The unit operated to the manufacturer's specifications.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 electronic patient gas system (epgs) fraction of inspired oxygen (fio2) and liters per minute (l/min) control knobs to make normal mechanical noises when performing calibration, flow testing and when controlled manually.No other noises were observed during evaluation.

• 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: 8740229
• MDR Text Key: 149380313
• Report Number: 1828100-2019-00341
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)110317
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

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: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 08/12/2019; 09/10/2019
• Supplement Dates FDA Received: 09/03/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1