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 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.The o2 sensor was returned to product surveillance lab for evaluation where the epgs calibrated and performed to specification.The product surveillance technician (pst) installed the returned o2 sensor into a lab-tested 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 and waited the 15 minute o2 sensor warm-up period.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 1.79 volts, which is within the specification of 0.55-2.758 volts.Setting the epgs at 21% o2 and 5 l/min, the ccm o2 reading was 19.6% and the reading on an o2 analyzer was 20.7%.Setting the epgs over a period of two days at 21% o2 and 5 l/min with consistent o2 readings from the ccm of 19.6% and 20.7% from the o2 analyzer.Nothing observed that would cause failure.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Upon receipt of the device, the user reported that the electronic patient gas system (epgs) failed the oxygen (o2) sensor reading accuracy portion of the verification/release test.At setpoint of 21%, the central control monitor (ccm) read 27.7%, servomex o2 analyzer read 21.0% which is outside the limit of +/- 3%.There was no patient involvement.

• 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: 5054405
• MDR Text Key: 25292070
• Report Number: 1828100-2015-00758
• 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
• Report Date: 09/03/2015

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: 10/29/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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