MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO 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 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The srt replaced the o2 sensor and the unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned for further evaluation.During laboratory evaluation, o2 sensor accuracy was not within specifications during initial testing after calibration.A second calibration after 20 minutes of testing, brought the o2 sensor within specifications.The product surveillance technician (pst) installed the returned o2 sensor into a lab-use only (luo) epgs and connected the epgs to a system-1 simulator and central control monitor (ccm).He connected the epgs to oxygen and air, entered a perfusion screen on the ccm.After the 15 minute warm-up period, calibration of the o2 sensor was initiated and passed.The measurement of the direct current (d/c) output voltage from the o2 sensor at 5 liters per minute (l/min) and 100% o2 was 2.01 volts which is within the specification of 0.55-2.758 volts.The pst observed nothing that would cause the reported failure.He tested the accuracy of o2% and found inaccuracies as shown below: o2% set point = 100%, ccm = 100%, external o2 analyzer = 99.5%; o2% set point = 80%, ccm = 79.9%, external o2 analyzer = 74.2%; o2% set point = 50%, ccm = 49.8%, external o2 analyzer = 45.2%; o2% set point = 30%, ccm = 29.4%, external o2 analyzer = 27.2%; o2% set point = 21%, ccm = 21.7%, external o2 analyzer = 20.8%.After 20 minutes of testing, a second calibration was performed and the o2% accuracy then met specifications as shown below: o2% set point = 100%, ccm = 100%, external o2 analyzer = 98.2%; o2% set point = 80%, ccm = 80.1%, external o2 analyzer = 77.6%; o2% set point = 50%, ccm = 49.7%, external o2 analyzer = 48.1%; o2% set point = 30%, ccm = 29.9%, external o2 analyzer = 29.4%; o2% set point = 21%, ccm = 20.4%, external o2 analyzer = 20.6%.Acceptable results for external o2 analyzer results: +/- 3% of ccm result.Acceptable results of ccm: +/- 7% of setpoint.

Event Description

Upon receipt of the device, the service repair technician (srt) reported the oxygen (o2) sensor failed o2 sensor accuracy testing on the electronic patient gas system (epgs).This is considered an "out of box" failure.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: TERUMO 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5538513
• MDR Text Key: 41781493
• Report Number: 1828100-2016-00223
• 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: 05/25/2016

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: 05/14/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 12804-144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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