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 Problems Inaccurate Flow Rate (1249); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The srt installed a new flowmeter and the ccm readings matched the external flowmeter.

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the central control monitor (ccm) displayed 10 liters/minute (l/min) while the external flowmeter showed 0.00 l/min.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

Additional information was received from the suppliers evaluation.The unit received reading -2.3 standard liters per minute (slpm) at zero flow.Unit differential pressure adc counts for this shift, with change from 11251 at time of production to 1747 upon receipt.Unit shows -1.1 millivolts (mv) offset, which is low but not enough to count for this error unless positive offset at time of initial calibration.The sensor was opened and three loose wire bonds were found on differential pressure sensor and the root cause for the erroneous sensor readings and failure.Failure is intermittent.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.During laboratory analysis, the product surveillance technician (pst) observed the flowmeter to operate as intended throughout the evaluation.The flowmeter was installed into a lab use only electronic patient gas system (epgs).He connected the epgs to a system 1 simulator and central control monitor (ccm), attached oxygen (o2) and air at 50 pounds per square inch (psi) and waited the warm up period for the o2 sensor.Calibration was initiated and passed.Air flow was set at five liters per minute (l/min) and the display on the ccm and external flowmeter was five l/min.Air flow readings matched the ccm and external flowmeter when set at two l/min and zero l/min.The flowmeter was physically agitated but did not cause any failure.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: 7635563
• MDR Text Key: 112579077
• Report Number: 1828100-2018-00328
• 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,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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
• Date Manufacturer Received: 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