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 03/23/2016

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 the laboratory evaluation, the o2 sensor accuracy was not within specifications during testing after calibration.The product surveillance technician (pst) removed the o2 sensor from the bag it came in and let it set vertically for 15 minutes outside of an epgs.After the 15 minutes, he installed the o2 sensor into a lab-use only (luo) epgs.The pst connected the luo epgs to a system-1 simulator and central control monitor (ccm).He connected the epgs to o2 and air, and 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 1.99 volts (v) which is within the specification of 0.55-2.758 volts.The pst tested the accuracy of o2% and found inaccuracies as shown in the table below.Flow was set at 5 l/min.The pst initiated a second calibration but after the second calibration, the inaccuracies of the o2% were the same as shown in the table below: o2% set point = 100%, ccm reading = 100%, analyzer reading = 96.6%.O2% set point = 80%, ccm reading = 80.0%, analyzer reading = 74.4%.O2% set point = 60%, ccm reading = 59.8% , analyzer reading = 58.1%.O2% set point = 40%, ccm reading = 39.8%, analyzer reading = 38.9%.O2% set point = 20%, ccm reading = 20.1%, analyzer reading = 20.7%.Specifications for oxygen analyzer 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 at 80% during phase 2 testing on the electronic patient gas system (epgs).The o2 sensor reading was 80.1% and servomex reading 72.8%, and acceptable result is +/- 3% per specifications.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: 5575978
• MDR Text Key: 43188513
• Report Number: 1828100-2016-00248
• 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: 06/21/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 12901-010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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