MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM 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 07/07/2015

Event Type  malfunction  

Event Description

Upon receipt of the device, the service repair technician (srt) reported that the oxygen (o2) sensor would not read within specification at the high end of the range (80%).Central control monitor (ccm) = 80.2%, reading from servomex analyzer = 84.4%.This was discovered during verification / release testing of the electronic patient gas system (epgs).There was no patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint was not duplicated during laboratory evaluation.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.The pst 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 (dc) output voltage from the o2 sensor at 5 liters per minute (lpm) and 100% o2 was 1.50 volts which is within the specification of 0.55-2.758 volts.The pst measured the o2 percentage with the epgs set for 5 lpm and 80% o2, the ccm reading was 79.3% and the reading of an o2 analyzer was 79.4%.The pst repeated calibration and measured o2% several times and the results were similar and within specifications.During visual inspection the pst observed nothing that would cause failure.A lab-tested epgs with the returned o2 sensor installed met specifications at 5 lpm and 80% o2.

• 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 SYSTEM CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4949623
• MDR Text Key: 6195172
• Report Number: 1828100-2015-00639
• 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: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 07/29/2015

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: 09/29/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 11954-199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SERVOMEX ANALYZER