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 03/25/2016

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.During laboratory evaluation the o2 sensor accuracy was not within specifications during initial testing after calibration.After 20 minutes of testing a second calibration was performed and the o2 sensor accuracy was still not within specifications at 80%.During visual inspection, nothing observed that would cause failure.The product surveillance technician (pst) installed the returned o2 sensor into a lab use only epgs and connected the epgs to a system 1 simulator and central control monitor (ccm).Connected the epgs to o2 and air, entered a perfusion screen on the ccm and waited the 15 minute o2 sensor warm-up period.After the 15 minute warm-up period, the pst operated the epgs at 100% o2 and 5 liters per minute (l/min) flow for one minute.After the minute at 100% oxygen and 5 l/min, 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 l/min and 100% o2 was 1.97 volts which is within the specification of 0.55-2.758 volts.The pst tested the accuracy of o2% and results are shown in the table below: o2% set point = 100% ccm = 100% external o2 analyzer = 97.5%.O2% set point = 80% ccm = 80.5% external o2 analyzer = 76.7%.O2% set point = 60% ccm = 59.2% external o2 analyzer = 56.4%.O2% set point = 40% ccm = 40.1% external o2 analyzer = 38.5%.O2% set point = 21% ccm = 20.9% external o2 analyzer = 20.9%.After 20 minutes of testing, a second calibration was performed and the o2% accuracy was still inaccurate at 80% as shown in the table below: o2% set point = 100% ccm = 100% external o2 analyzer = 98.0%.O2% set point = 80% ccm = 78.5% external o2 analyzer = 76.3%.O2% set point = 60% ccm = 60.0% external o2 analyzer = 58.3%.O2% set point = 40% ccm = 39.1% external o2 analyzer = 38.3%.O2% set point = 21% ccm = 20.4% external o2 analyzer = 20.5%.Specifications for external o2 accuracy: +/- 3% of o2 set point.Specifications of ccm o2 reading: +/- 7% of o2 set point.

Event Description

Upon receipt of the device, the service repair technician (srt) reported that the oxygen (o2) sensor failed reading accuracy test at 80% on the electronic patient gas system (epgs) during phase 2 testing.The o2 sensor reading was 80.4% and servomex o2 analyzer reading 74.6%, acceptable result is +/-3% per specification.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 ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5584028
• MDR Text Key: 43586308
• Report Number: 1828100-2016-00253
• 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: 06/14/2016

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: 12804-128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• 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