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 Out-Of-Box Failure (2311); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Failure to calibrate, 2311 - out-of-box failure.O2 sensor.Per srt, during testing the central control monitor (ccm) read 76.4 while the o2 analyzer read 79.8.Specifications to pass testing are +/- 3% of each other.

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the oxygen (o2) sensor failed "o2 sensor calibration" testing at 80%.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Per the manufacturer's supplier, the out of range readings were confirmed.The cause was determined to be a crack or fissure in the cathode.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) installed the oxygen (o2) sensor into a lab use (epgs).He connected the epgs to a system 1 simulator and central control monitor (ccm), attached o2 and air at 50 psi and entered a perfusion screen on the ccm.After the 15-minute warm-up period, calibration of the epgs was initiated and passed.The measurement of the direct current (d/c) output voltage from the o2 sensor at 5 l/min and 100% o2 was 1.60 volts, within the specification of.55-2.758 volts.After calibration, set flow at 5 l/min and o2 at 80%.The ccm displayed 80.3% while an external analyzer displayed 76.2%.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
• MDR Report Key: 7332195
• MDR Text Key: 102215868
• Report Number: 1828100-2018-00119
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2018

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: 04/18/2018
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/29/2018; 08/10/2018
• Supplement Dates FDA Received: 04/23/2018; 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1