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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

Per the facility's sales associate, the o2 sensor would not calibrate.It had calibrated fine previously in the day.During the read verification, there was no flow on the flow meter and a kinked line was discovered.The flow then worked fine but the o2 analyzer would not calibrate after multiple attempts.The field service representative (fsr) duplicated the issue that the gas system failed calibration.The fsr replaced the o2 sensor and preformed release testing.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 oxygen (o2) analyzer was not calibrating.As a result, an alternate device was employed.There was no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated block: h6 the product surveillance technician (pst) could not duplicate the issue.The oxygen (o2) sensor was successfully calibrated and meets expectations for performance during use.No issues observed.Per data analysis on 02-nov-2020 the gas system is successfully calibrated at 08:07:03.The o2 sensor value at calibration was 1530megavolt (mv) which is a good value.At 11:31:34 calibration was attempted a second time and failed with 'flow out of range' (10.23 liters per min).Another attempt failed with 'o2 sensor out of range at calib (sensor value = 2733 mv - too high).Additional attempts failed in the same way with the sensor value being too high.It is possible a blocked line damaged the o2 sensor and the sensor should probably be replaced.The log confirms the complaint.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2020 the gas system calibrated successfully at 08:07:03.The oxygen (o2) sensor value at calibration was 1530 millivolts (mv), which is a good value.At 11:31:34 calibration was attempted for a second time and failed with a 'flow out of range' message (10.23 liters per minute).Another attempt failed with an 'o2 sensor out of range with calib' message (sensor value = 2733 mv - too high).Additional attempts failed in the same way with the sensor value being too high.It is possible the blocked line or damage to the o2 sensor and the sensor should be replaced.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.

• 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: 10907424
• MDR Text Key: 221262673
• Report Number: 1828100-2020-00459
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)180120
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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: 11/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1