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 Problems Loose or Intermittent Connection (1371); Sensing Intermittently (1558)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During laboratory evaluation, 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 psi, entered a perfusion screen on the ccm and waited the 15 minute o2 sensor 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 1.84 volts, within the specification of 0.55-2.758 volts.The pst downloaded the data logs and found a "19012 error code": ¿o2 sensor out of range at cal¿ errors.Per the field service handbook this suggests that the sensor is not plugged in all the way, which will give this error.The pst observed the o2 sensor cable was not fully inserted into the o2 sensor causing the o2 % reading on the (ccm) to display as all dashes.When the connector was not making full contact, the epgs would intermittently fail calibration.The pst pushed the connector into the o2 sensor so that it was fully seated.The epgs calibrated and no further errors occurred and the o2% reading on the ccm was displayed as normal.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the electronic patient gas system (epgs) was reading intermittently.The device was not changed out, as they used a stand alone gas blender to finish the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The electronic patient gas system (epgs) was last reconditioned on (b)(6) 2014.The service repair technician (srt) reconditioned the epgs per the manufacturer's specification.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

Additional information from the perfusionist (ccp) on 25-sep2015: the ccp did not recall if there was any specific message displayed.He thinks the gas system just would not calibrate, and there were no alarms.The ccp stated there was no gas leaks observed.The ccp stated the circuit was set-up as such: the medical air and oxygen are supplied to the pump via standard quick disconnect fittings and appropriate yellow and green gas hoses.The gas line exits the system-1 and is connected to a sevoflurane vaporizer.All connections were verified and the filling port was checked.The gas line exits the vaporizer and is connected to a gas flowmeter, which matched the gas flow displayed on the system-1 display.The gas line then is connected to a green gas filter just prior to the oxygenator gas inlet.As per log analysis, the issue may have occurred but did not trigger an event.On 25-aug-2015, calibration attempts fail with "o2 sensor out of range at calib (4007, 4.007 v)".This would cause the oxygen (o2) value to be dashes as reported.This indicates a problem with the o2 sensor or the connection to the o2 sensor.O2 sensor was shipped to the customer on 07/09/15 and it was within it's life span of 6 months.It is unknown how this cable became loose.

Event Description

Correction: an independent pole mounted gas blender was used for later cases, until the epgs issue was addressed (repaired).Per the clinical review on 23-sep-2015: according to the perfusionist (ccp), the electronic patient gas system (epgs) calibrated successfully prior to cardiopulmonary bypass (cpb).During cpb, the measured fraction of inspired oxygen (fio2) value on the central control monitor (ccm), would display (- - -) intermittently.There was no issue with actual gas delivery and they were able to use the sliders to adjust gas supply levels.When the measured fio2 displayed (- - -), they used the set point when making adjustments.Blood gas measures were used to confirm adequate gas exchange.The epgs was used for the entire procedure.After the procedure, while the issues were being addressed, an independent pole mounted gas blender was used for a few cases.The case was completed successfully, without delay and without associated blood loss.There was no harm of the patient.

• 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: 5080887
• MDR Text Key: 26036838
• Report Number: 1828100-2015-00797
• 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: Followup,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• 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: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2008
• 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