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

Model Number 801188

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's perfusionist, this has occurred before.The field service representative (fsr) was unable to duplicate the reported complaint.He replaced the epgs as a precaution.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) was not transferring oxygen (o2) as it was set to.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2018, the epgs calibrated prior to going on bypass without issue.Upon initiation of bypass, the sweep gas was set at 250 ml/min and fio2 was set at 100% on a neonate patient.The perfusionist noticed that the blood did not look as if o2 was being transferred to the oxygenator.She also noted that there was a louder than normal clicking sound from the epgs.She proceeded to take an arterial blood gas and recalls that her blood parameter monitor (bpm) was reading in the 50 mmhg range.She confirmed that the first gas on bypass had a partial pressure of oxygen (po2) of 76 mmhg.She increased her sweep gas to 400 ml/min on the epgs and the oxygen transfer was then noticeable.She proceeded to use the epgs throughout the remainder of the procedure and kept her flow at about 400 ml/min to the oxygenator, and the patients po2 values were between 200 and 400 mmhg throughout the duration of the procedure.The incident did not delay the continuation of the surgical procedure, and there was no harm or blood loss observed.The field service representative (fsr) tested the epgs and it performed to specifications.For preventive measures, he did exchanged the epgs on that heart lung machine (hlm).I spoke with her about occlusions in her line with the vaporizer being in line and that sometimes that is a source of decreased flow to the oxygenator.Additionally, this is a pediatric hospital, therefore having a gross flow meter that only has large graduations does not enable the perfusionist to discern the flow at low gas flows, therefore the team does not use the external flow meter.

Manufacturer Narrative

The reported 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.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) was unable to duplicate the reported complaint.The electronic patient gas system (epgs) was connected 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 o2 sensor warm-up period.Calibration was then initiated and passed.The measurement of the direct current (d/c) output voltage from the o2 sensor at five liters per minute (lpm) and 100% o2 was 1.66 volts (v), within the specification of 0.757-2.551v.Per data log analysis, on 10-may-2018 the gas system (version 1.30) is successfully calibrated at 10:22:28 am.13:22:02, flow set to 0.2 l/min; 13:25:56, flow set to 0.4 l/min; 13:26:59, flow set to 0.2 l/min; 13:29:42, flow set to 0.0 l/min; 14:26:11, fio2 is set to 100%; 14:38:34, flow set to 0.2 l/min; 14:39:24, o2 sensor and blender disagree (blender = 100%, sensor = 19.8%); 14:39:57, flow set to 0.2 l/min; 14:40:18, flow set to 0.4 l/min.After this there were many flow changes with no indications of an issue.The log confirms the complaint where fraction of inspired oxygen (fio2) was set to 100%, flow was set to 0.2 l/min and fio2 remained at 19.8%.The service repair technician (srt) was unable to duplicate the reported complaint.He replaced the internal flowmeter as a precaution.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

Corrected block: device available for evaluation.

• 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: 7566098
• MDR Text Key: 110197951
• Report Number: 1828100-2018-00292
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYGENATOR; VAPORIZER