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

Model Number 801074

Device Problems Out-Of-Box Failure (2311); Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The srt found the ccm read 29.2% at a setpoint of 21%.The srt installed a new o2 sensor.The product surveillance technician (pst) confirmed the o2 sensor was defective.The o2 sensor was installed in a lab use ony epgs and the electronic patient gas system (epgs) was connected 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 warmup period.After the 15 minute warmup period, calibration of the epgs was initiated and passed.The pst tested the accuracy of the o2% output compared to the setpoint and the external analyzer reading was out of specification as compared to the o2% setpoint at multiple set points between 40% - 100%.Specifications for oxygen analyzer accuracy: +/- 3% of o2 set point at calibration flow and pressure.The measurement of the dc output voltage from the o2 sensor at 5 l/min and 100% o2 was 2.15 volts which is within the specification of.55-2.758 volts.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 oxygen (o2) sensor failed the accuracy test.This is an out of box failure.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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6367970
• MDR Text Key: 69019243
• Report Number: 1828100-2017-00102
• 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: 06/01/2017

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: 05/03/2017
• 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: 02/06/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• 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: Reuse
• Patient Sequence Number: 1