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 801188

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Biomed replaced the cable to the affected unit and the epgs still did not function.He tried another gas mixer and it worked.The biomed spoke with manufacturer technical support and it was determined that the epgs was the issue.During the laboratory evaluation, all functions of the epgs functioned as designed during testing.The product surveillance technician (pst) connected the epgs to a system-1 simulator and central control monitor (ccm), attached oxygen (o2) and air at 50 pounds per square inch (psi), entered a perfusion screen on the ccm, and waited the 15 minute warm-up period.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 1.83 volts (v), within the specification of 0.55-2.758 v.The pst operated the epgs through its range of o2 and air with all functions operating as designed.Checked internal connections with nothing found that would cause failure.

Event Description

The user facility's biomedical engineer (biomed) reported that during field service installation there was an "out of box" failure with the electronic patient gas system (epgs).There was no patient involvement.

Manufacturer Narrative

There are no errors reported in the data logs.The gas system in each case was not powered up long enough for the warm up period (15 minutes), therefore calibration was never attempted.There is no actual indication of a problem in the log file.Udi: (b)(4).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

As per service repair technician (srt), the unit was returned with a cable and an air filter for repair.Power cycled the unit and could not duplicate the complaint.Per service management, the electronic patient gas system (epgs) pod was replaced as a precaution.No need for full reconditioning as the device was not used.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: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5966391
• MDR Text Key: 55272189
• Report Number: 1828100-2016-00634
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2016

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: Health Professional
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Other Device ID Number: GTIN (01)0088679900588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/27/2016; 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2003
• 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