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 Calibration Problem (2890)

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

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate the reported complaint.He replaced the oxygen (o2) sensor.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 use of the device for a cardiopulmonary bypass (cpb) procedure, the unit prompted the user to recalibrate the electronic patient gas system (epgs) following initial calibration.No other details regarding the nature of this event were provided.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the oxygen (o2) sensor to pass calibration 10 consecutive times.The unit operated to the manufacturer's specifications.Per data log analysis, it was confirmed that the initial calibration failed displaying an 'o2 sensor out of range' at 7:01:45 am.The user tried to recalibrate and received the same error at 8:42:05 am and at 8:43:45am.At 13:03:19 calibration was started and successfully passed at 13:05:07.Between the failed gas calibrations the fraction of oxygen (fio2) and flow was changed several times and there were o2 sensor and blender disagree errors.

Event Description

Additional information received that the reported issue occurred during set-up.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.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: 9494504
• MDR Text Key: 203712333
• Report Number: 1828100-2019-00675
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)080416
• 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: 02/10/2020

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: 12/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/09/2020; 01/29/2020
• Supplement Dates FDA Received: 01/29/2020; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1