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 Inaccurate Flow Rate (1249)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the epgs.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the electronic patient gas system (epgs) had inaccurate flow readings.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

During laboratory analysis, the product surveillance technician (pst) observed inaccurate flow readings to be the result of a defective internal flowmeter.Per supplier evaluation, the unit was received with zero flow reading at zero flow.Erroneous absolute pressure was reading 19.87 pounds per square inch absolute (psia) at atmosphere (13.64 psia).Register inspection showed that the absolute pressure sensor signal has shifted from time of initial calibration, with sensor read counts shifting from value of 30355 to 38411.This shift accounts for erroneous pressure readings which accounts for error in flow.Increased pressure will increase standardized mass flow rate above actual.The solder joints were examined and deemed to be of good quality.The sensor was opened and manual pull test was conducted.All wire bonds on the differential pressure sensor passed the pull test, however, all the wire bonds on the absolute pressure sensor were loose and defective.The defective sensor was determined to be the cause of non-conformity.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: 8066645
• MDR Text Key: 127084334
• Report Number: 1828100-2018-00583
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)090303
• 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,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: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 12/17/2018; 01/18/2019; 04/17/2019
• Supplement Dates FDA Received: 01/11/2019; 02/08/2019; 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 FLOW METER; VAPORIZER