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 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The srt replaced the o2 sensor in the electronic patient gas system (epgs) unit and the unit operated to manufacturer specifications and was returned to clinical use.As per service repair technician the voltage from the o2 (oxygen) sensor with 100% oxygen was 1.947vdc, which is within spec.With the blender set point at 30% the ccm (central control monitor) reported 33.4%, the external o2 analyzer showed the actual o2 as 30.0% indicating the oxygen sensor failure.Evaluation is in progress, but not yet concluded.

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the electronic patient gas system (epgs) failed the oxygen sensor reading accuracy portion of the verification/ release testing.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) calibrated the electronic patient gas system (epgs) with the suspect oxygen (o2) sensor and the calibration passed.The o2 percentages displayed on the central control monitor (ccm) and measured with an external oxygen analyzer were outside of specifications compared to the epgs set point.The measurement of the dc output voltage from the o2 sensor at 5 l/min and 100% o2 was within the specification.There was nothing noted upon visual inspection of the o2 that would cause the failure.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: 6033549
• MDR Text Key: 57683381
• Report Number: 1828100-2016-00684
• 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: 11/14/2016

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: 12/13/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 13809-122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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