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

Model Number 801074

Device Problems Out-Of-Box Failure (2311); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

After the calibration error, the manufacturer's subsidiary service engineer reinstalled the old o2 sensor and it passed calibration.

Event Description

It was reported that during installation of the oxygen (o2) sensor the electronic patient gas system (epgs) was unable to be calibrated and displayed a "service gas system" error message.There was no patient involvement.

Manufacturer Narrative

Useage of device: 'reuse' was inadvertently checked on the previous submission.

Manufacturer Narrative

During laboratory evaluation, the product surveillance technician (pst) observed there to be no calibration or "service gas system" error messages.The electronic patient gas system (epgs) was connected to a system 1 simulator and a central control monitor (ccm) attaching oxygen (o2) and air at 50 per square inch (psi).After the 15 minute warm-up period, calibration was initiated and passed.The measurement of the direct current (dc) output voltage from the o2 sensor at 5 liters per minute (l/min) and 100% o2 was 1.70 volts, which was within the specification of.55-2.758 volts.The unit was calibrate six more times with no failures detected.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: 7522578
• MDR Text Key: 108752923
• Report Number: 1828100-2018-00260
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

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: Other
• Device Expiration Date: 05/31/2018
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/18/2018; 06/12/2018
• Supplement Dates FDA Received: 06/12/2018; 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1