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 Failure to Calibrate (2440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the reported complaint.He attempted to calibrate the epgs multiple times and was unsuccessful.He replaced the oxygen (o2) sensor and performed release/verification testing successfully.The unit operated to the manufacturer's specifications.The suspect part 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 calibrate.The perfustionist attempted to calibrate the epgs multiple times prior to the case without success.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Updated blocks: b5 and h6.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician was unable to duplicate the reported complaint.The returned oxygen (o2) sensor was installed into a lab use only electronic patient gas system (epgs) and the epgs passed calibrations multiple times.Per data log analysis, on (b)(6) 2020 the gas system is successfully calibrated at 22:19:09.At 23:38:47 the gas system reported 'o2 sensor and blender disagree' (sensor = 0 %, blender = 56.0 %).This would cause an indication the gas system need to be calibrated.Calibration is attempted three times and fails each time with 'o2 sensor out of range at calib' (o2 sensor value = 0).After the system is power cycled calibration is successfully performed on (b)(6) 2020.It appears the o2 sensor had an intermittent issue causing calibration to fail.The log confirms the complaint.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Additional information was received that the device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• 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: 9933482
• MDR Text Key: 200026701
• Report Number: 1828100-2020-00152
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)071211
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• 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: 03/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1