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

Model Number 801074

Device Problems Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During routine testing at service center the service repair technician (srt) found that the electronic patient gas system (epgs) failed oxygen (o2) sensor accuracy tests at 21% and 30% with a new oxygen sensor installed.Testing at 21% test, the set-point on the ccm was 21%.Ccm read oxygen was at 24% and oxygen analyzer read 20.9%.Testing at 30% test, the set-point on the ccm was 30%.Ccm read oxygen was at 30.8%, oxygen analyzer read oxygen was at 27.7%.The srt replaced the oxygen sensor with another new oxygen sensor.The reported complaint was not duplicated as per laboratory evaluation.The oxygen sensor was tested and passed calibration.The measurement of the dc output voltage from the o2 sensor at 5 l/min and 100% o2 was 1.64 volts which is within the specification of.55-2.758 volts.The operated epgs through its range of oxygen percentages and measured the o2% output on the ccm and with an external oxygen analyzer.No inaccuracies were found.The unit meets specification.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

The service repair technician (srt) reported that during routine testing of the device at the service center, the device failed oxygen sensor accuracy tests.The device was replaced with new part.There was no patient involvement.

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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6204671
• MDR Text Key: 63651465
• Report Number: 1828100-2016-00821
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

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: 12/13/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1