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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) failed calibration four different times.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed calibration to fail due to a defective flow meter.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.

Manufacturer Narrative

The reported complaint was confirmed via data logs.The suspect unit was not returned to the manufacturer so no further evaluation could be conducted.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

Per the manufacturer's subsidiary, the hose connections were checked and no gas leaks were found.There were also no error messages or alerts noted.Per data log analysis, only a system log was provided, and the system log was exported on (b)(6) 2018.This issue appears to have occurred on that date, the system log reported 5 occurrences of "flow mechanical fault" during calibration.This indicates the calibration flow could not be achieved, possible a binding flow knob or flow meter issue.

Event Description

Additional information received stating that the event did not result in any delay in beginning or continuing the surgical procedure.

Manufacturer Narrative

Software data logs were returned to the manufacturer on 28-nov-2018.

Manufacturer Narrative

The reported complaint was confirmed.Per the suppliers evaluation, upon initial inspection, adc counts indicate a damaged pressure sensor.Differential pressure readings shifted dramatically from the time it left the factory (10,051 to 1,142).Similarly, the absolute pressure and bridge signals show significant shift (30,262 to 25,547 and 38,573 to 32,253 respectively).These shifts were confirmed when raw sensor voltage output were checked, the differential output shifting negative by over 800 millivolts (mv).This sensor usually outputs no more than 200 mv over its span, so this shift would nullify any shift due to flow and always read zero (or negative flow).When flow is requested, meter would read zero flow and the valve would open more and more until opened fully in an attempt to make desired flow rate.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: 8125280
• MDR Text Key: 129068130
• Report Number: 1828100-2018-00614
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/26/2019

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: 04/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 11/28/2018; 01/07/2019; 02/07/2019; 04/24/2019; 06/13/2019
• Supplement Dates FDA Received: 12/16/2018; 01/30/2019; 02/13/2019; 05/17/2019; 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-04/12/19-002-C
• Patient Sequence Number: 1
• Treatment: MECHANICAL GAS FLOWMETER; OXYGENATOR