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

Model Number 811104

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Per the srt, when the electronic patient gas system (epgs) was set to zero, the central control monitor (ccm) displayed a flow of 10.00 liters per minute (l/min) but an external flow meter showed 0.00 l/min.He replaced the flow meter.The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) observed the flowmeter to initially cause inaccurate ccm displays and was producing inaccurate output voltages during zero air flow.After a calibration and period of operation of a lab use only (luo) epgs with the flowmeter installed, the flowmeter was functioning normally and was producing proper output voltages.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

The service repair technician (srt) reported that during routine testing of the device at the service center, the flowmeter had incorrect flow values.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 mass flow reading was 0.53 standard liters per minute (slpm) at zero flow and well out of tolerance.This flow reading corresponds to shift in dp sensor read value of 13979 compared to original factory value of 11494.When offset shifts compensated for the device tare, as found data within tolerance, outputs checked and tracked appropriately.The sensor was discovered with defective wire bonds.Pull tests confirmed wire bonds loose and it failed pull test on the differential pressure sensor.It is believed that wire bonds are the cause of the flow offset shift of the flow meter.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: 8130408
• MDR Text Key: 129480544
• Report Number: 1828100-2018-00617
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,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: Other
• Device Model Number: 811104
• Device Catalogue Number: 811104
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 01/15/2019; 04/17/2019
• Supplement Dates FDA Received: 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