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 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The fsr replaced the suspect o2 sensor with a new o2 sensor and performed a successful calibration and verified fio2 operated within specification of +/- 3% functional specification at max, mid and min blender settings.The unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned to the manufacturer for further evaluation.

Event Description

When installing a new oxygen (o2) sensor, the field service representative (fsr) reported that the o2 sensor failed initial calibration, but passed two subsequent calibrations.Performance test of the electronic patient gas system (epgs) using an external o2 analyzer showed that new sensor accurately measured 100% fraction of inspired oxygen (fio2) set output, but displayed 38% fio2 when epgs was set to 21% (external oxygen analyzer confirmed that epgs output was really 21%).There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During the laboratory evaluation, a lab-tested electronic patient gas system (epgs) would not pass calibration with the returned oxygen (o2) sensor installed.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 central control monitor (ccm).He connected the epgs to oxygen and air, entered a perfusion screen on the ccm.After the 15 minute warm-up period, calibration of the o2 sensor was initiated and failed.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 2.93 volts which is outside the specification of 0.55-2.758 volts.The pst initiated two more calibrations and both failed.No further testing could be accomplished with calibration failing.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: 5285944
• MDR Text Key: 33742341
• Report Number: 1828100-2015-01024
• 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: 02/26/2016

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: 12/23/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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