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 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The voltage from the o2 sensor with 100% oxygen was 2.141 volts direct current (vdc), which was within specification.With the blender setpoint at 30%, the central control monitor (ccm) reported 29.5%, the external o2 analyzer showed the actual o2 as 26.3%.The srt installed a new o2 sensor, ran verification test and the unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned for further evaluation.During the laboratory evaluation, o2 sensor accuracy was not within specifications during initial testing after calibration.After 20 minutes of testing a second calibration was performed, o2 sensor accuracy was 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 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 1.94 volts (v) which is within the specification of 0.55-2.758 volts.The pst tested the accuracy of o2% as shown in the table below: o2% set point = 100% ccm reading = 100% external analyzer reading = 97.8%; o2% set point = 80% ccm reading = 80.1% external analyzer reading = 72.2%; o2% set point = 60% ccm reading = 60.5% external analyzer reading = 55.4%; o2% set point = 40% ccm reading = 39.6% external analyzer reading = 36.4%; o2% set point = 30% ccm reading = 29.4% external analyzer reading = 26.5%; o2% set point = 21% ccm reading = 21.9% external analyzer reading = 20.4%.After 20 minutes of testing, a second calibration was performed and o2% accuracy was within specifications as shown in the table below: o2% set point = 100% ccm reading = 99.0% external analyzer reading = 97.1%; o2% set point = 80% ccm reading = 80.4% external analyzer reading = 79.0%; o2% set point = 60% ccm reading = 60.3% external analyzer reading = 59.3%; o2% set point = 40% ccm reading = 39.8% external analyzer reading = 39.3%; o2% set point = 30% ccm reading = 29.2% external analyzer reading = 29.4%; o2% set point = 21% ccm reading = 20.2% external analyzer reading = 20.6%.Specification for oxygen accuracy: +/- 3% of o2 set point; specification of ccm oxygen reading: +/- 7% of o2 set point.

Event Description

Upon receipt of the device, the service repair technician (srt) reported that the electronic patient gas system (epgs) failed the oxygen (o2) sensor reading accuracy portion of the verification test during phase 2 testing.This is considered an "out of box" falure.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: 5619460
• MDR Text Key: 44472840
• Report Number: 1828100-2016-00297
• 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: 06/27/2016

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: 12901-028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• 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