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

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per fsr, during installation the epgs failed calibration and displayed a "gas system: knob adjust only" message.He replaced the epgs.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during field service installation of the device, the electronic patient gas system (epgs) failed calibration during release testing.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the software module to be defective, especially when cold.The pst connected the electronic patient gas system (epgs) to a system 1 simulator, attached oxygen (o2) and air at 50 pounds per square inch (psi) 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 5 liters per minute (l/min) and 100% o2 was 1.71 volts, within specifications of.55-2.758 volts.The epgs was placed into a cold soak at 10 degrees celsius (c) for three hours.When removed from the cold soak, the epgs was unable to be calibrated.Temporarily replacing the software module allowed the epgs to pass calibration.The product will be sent to service to be brought to manufacturer¿s 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.

• 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: 7450367
• MDR Text Key: 106736379
• Report Number: 1828100-2018-00199
• 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
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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 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: 04/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1