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 Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

The user facility's manufacturer trained biomedical technician attempted to calibrate the epgs three times and failed all three times.He changed out the oxygen (o2) sensor and then noticed that the flow knob was knocking or tapping.The suspect part was returned to the manufacturer for further evaluation.

Event Description

The biomedical technician reported that during preventive maintenance (pm) of the device, the electronic patient gas system (epgs) would not pass calibration.There was no patient involvement.

Manufacturer Narrative

The reported complaint 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

The reported complaint was confirmed.Per supplier evaluation, upon power-up the devices absolute pressure readings found to be out of tolerance, reading 6.62 pounds per square inch absolute (psia) at atmosphere (13.68 psia at time of test).This erroneous reading was confirmed by inspection of the sensor signal values, with signal reading 21674 counts compared to a value of 30250 at time of manufacturer.This signal drift accounts for the lower pressure reading.As a result of lower pressure reading, as found mass flow is approximately half of actual value.Output voltages checked and found to be within tolerance.No other potential issues identified in evaluation.Wire bond on absolute pressure sensor failed wire bond pull test.Faulty connection of wire bond accounted for the shift in pressure reading.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) observed the electronic patient gas system (epgs) that would not calibrate because of a defective internal flowmeter.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: 8021364
• MDR Text Key: 125780695
• Report Number: 1828100-2018-00566
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 0086799000588
• UDI-Public: (01)0086799000588(11)110127
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• 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: 04/17/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 11/20/2018; 01/14/2019; 04/17/2019
• Supplement Dates FDA Received: 12/11/2018; 01/31/2019; 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-04/08/19-002-C
• Patient Sequence Number: 1
• Treatment: MECHANICAL FLOWMETER