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 Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the field service representative (fsr), the user facility leaves their systems powered on at all times to keep the batteries charged.The gas lines do get disconnected when not in use.The epgs had been logging oxygen (o2) hours while the system was left on.The fsr was able to walk the user facility through on how to access the service screen and reset the o2 hours to zero.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the system was alarming and a "service gas system" error message was displayed.The electronic patient gas system (epgs) was controlled manually.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The user facility's perfusionist reset the oxygen (o2) hours and the issue resolved.The field service representative (fsr) replaced the o2 sensor.The unit operated to manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Manufacturer Narrative

Please disregard previously reported information as this complaint has been determined to be not mdr reportable.The device met specification and performed as intended, therefore did not malfunction.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) was unable to confirm the reported issue.He installed the oxygen (o2) sensor into a lab use only electronic patient gas system (epgs).The epgs was connected to a system 1 simulator and central control monitor (ccm), attached o2 and air at 50 pounds per square inch (psi), entered a perfusion screen on the ccm and waited the warm-up period.Calibration was initiated and passed.The measurement of the direct current (dc) output voltage from the o2 sensor at five liters per minute (l/min) and 100% o2 was 1.82 volts, within the specification of 0.757-2.551 volts.Calibration was repeated and passed.The epgs was set at five l/min and 80% o2 and the o2% reading on the ccm and external flowmeter were within manufacturer's specifications.

• 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: 7481404
• MDR Text Key: 107742061
• Report Number: 1828100-2018-00229
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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
• Other Device ID Number: GTIN: (01)00886799000588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1