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 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) removed the electronic patient gas system (epgs) and oxygen (o2) sensor and found no abnormalities.He reinstalled the system and calibrated 10 times without failure.The next day, the issue reoccurred and he verified the reported complaint.The epgs failed calibration on his first attempt.He replaced the epgs.The unit operated to the manufacturer's specifications.The suspect unit 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 fraction of inspired oxygen (fio2) started not calibrating or failing after the internal flow meter sensor was replaced.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Per the service repair technician (srt) the oxygen sensor will be replaced as part of the reconditioning process.

Event Description

Additional information was received that an alternate device was employed.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the electronic patient gas system (epgs) to fail calibration.Upon inspection, the oxygen (o2) sensor cartridge was found to be leaking.A lab use only o2 sensor cartridge was installed on the user facility epgs and the unit passed calibration with no errors.

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: 9233904
• MDR Text Key: 165496653
• Report Number: 1828100-2019-00557
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)110301
• 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,Followup,Followup
• Report Date: 04/08/2020

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: 10/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 12/10/2019; 03/27/2020
• Supplement Dates FDA Received: 11/22/2019; 12/16/2019; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1