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 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to mdr #1828100-2015-00808.The srt reported the voltage from the o2 sensor with 100% oxygen was 1.879 volts direct current (vdc), which is within specification.With the blender setpoint at 80% the central control monitor (ccm) reported 82.5%, the external o2 analyzer showed the actual o2 as 76.5%, which is outside the +/- 3% acceptance specification.The srt installed a new o2 sensor and ran applicable phase 2 tests.The unit operated to manufacturer specifications and was returned to clinical use.During the laboratory evaluation, a lab-use only (luo) epgs was within specifications for o2% with the returned o2 sensor installed.The product surveillance technician (pst) installed the returned o2 sensor into a luo epgs and connected the epgs to a system-1 simulator and 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 1.81 volts which is within the specification of 0.55-2.758 volts.The pst set the test epgs at 5 l/min and 80% o2.The ccm displayed 79.4% and an external o2 meter displayed 79.8%.Also tested the o2 sensor at 21%, 50% and 100%.Nothing was observed that would cause failure.

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the electronic patient gas system (epgs) failed the oxygen (o2) sensor reading accuracy portion of the verification test.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: 5444346
• MDR Text Key: 38997740
• Report Number: 1828100-2016-00094
• 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: 04/19/2016

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: 05/12/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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