MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801074

Device Problems Gas Output Problem (1266); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During laboratory analysis, the product surveillance technician (pst) installed oxygen (o2) sensor into a lab use only electronic patient gas system (epgs) to a system 1 simulator and central control monitor (ccm).He connected the epgs to o2 and air, entered the perfusion screen on the ccm and waited the 15 minute warm-up period.After the warm-up period, the calibration of the epgs was initiated and passed.The measurement of direct current (dc) output voltage from the o2 sensor was at 5 l/min and 100% o2 was 1.58 volts which is within the specifications of.55-2.758 volts.Inaccuracies were found when he tested the o2% accuracy output at 80%.Per service repair technician (srt), the o2 sensor calibration test had a set point of 80%.The central control monitor (ccm) reported 80.5%, the actual value on the external gas analyzer was 77.4%.The srt replaced the o2 sensor.The epgs operated to the manufacturer's specifications.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

The service repair technician (srt) reported that during routine testing of the device at the service center, the unit failed accuracy testing.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: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7037845
• MDR Text Key: 93109423
• Report Number: 1828100-2017-00528
• 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: 03/09/2018

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: 01/26/2018
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1