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 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The voltage from the o2 sensor with 100% oxygen was 1.340 volts direct current (vdc), which is within specifications.With the blender setpoint at 21%, the central control monitor (ccm) reported 30.5%, which is out of specifications.The external o2 analyzer showed the actual o2 as 20.9%.The srt re-calibrated and received the same results.

Event Description

Upon receipt of the device, the service repair technician (srt) reported that the oxygen (o2) sensor failed the reading accuracy portion of the verification test for the electronic patient gas system (epgs).There was no patient involvement.

Manufacturer Narrative

Per evaluation, the oxygen (o2) sensor passed voltage but failed o2 reading accuracy (complaint condition was duplicated).The voltage reading was 1.49 volts which was within specification.With the blender setpoint of 21%, the central control monitor (ccm) reading was 26.8% and o2 analyzer reading was 20.8% (out of specification).With the blender setpoint of 30%, the ccm reading was 31.0% and o2 analyzer reading was 25.6% (out of specification).With the blender setpoint of 80%, the ccm and o2 analyzer readings were in acceptable range and met specification.

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: 5346663
• MDR Text Key: 35558214
• Report Number: 1828100-2016-00002
• 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,Followup
• Report Date: 03/10/2016

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: 03/23/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2016; 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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