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 Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

Lot #/model #: (21)00877.(b)(4).The defective o2 sensor was tested by the product surveillance technician.Oxygen percentages displayed on the ccm and measured with an external oxygen analyzer were within specifications compared to the set point.Nothing observed that would cause failure was noted during visual inspection.Testing evaluation included installing the returned o2 sensor into a lab use only epgs and connected the epgs to a system 1 simulator.Connected the epgs to oxygen and air, entered a perfusion screen on the ccm and waited the 15 minute warmup period.After the 15 minute warmup period, calibration of the epgs was initiated and passed.The measurement of the dc output voltage from the o2 sensor at 5 l/min and 100% o2 was 1.74 volts which is within the specification of.55-2.758 volts.Operated the epgs through its range of o2 percentages and measured the o2% output on the ccm and with an external o2 analyzer.The results are shown in the table below with no inaccuracies found.(b)(6).

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center the unit failed o2 sensor accuracy tests in phase 2 testing.It was reported that the o2 sensor failed out of the box.No patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) replaced the oxygen (o2) sensor.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: 6204293
• MDR Text Key: 63626901
• Report Number: 1828100-2016-00820
• 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: 03/21/2017

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
• Other Device ID Number: (01)00886799000588(11)090224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• 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