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

Model Number 802018

Device Problems Failure to Sense (1559); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded per fsr, when the flow module was installed he was unable to get a flow reading and only dashes appeared.He replaced the flow module.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during installation of the device, no flow readings were displayed.There was no patient involvement.

Manufacturer Narrative

(b)(4).During laboratory analysis, the product surveillance technician (pst) connected the device under test (dut) to the system 1 simulator using lab peripherals to construct a basic centrifugal water loop with flow sensor on 3/8¿ tubing.The pst powered on the test setup, opened perfusion window and assigned the dut flow module.Observed proper flow immediately on central control monitor (ccm) and pump controller display.The pst agitated the sensor cable at the module connection.No anomalies were observed as the result of cable agitation.Left running at 1800 rpm for about 45 minutes, then found flow display to be three dashes (¿---¿).This indicates loss of flow data.This duplicates the reported complaint.The ccm status bar at the top of the perfusion screen also displays ¿flow: check sensor¿ when it fails.The cause of failure is the flow module application board.The cause of failure is the flow module application board 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

Udi (b)(4).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.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
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7133063
• MDR Text Key: 95658756
• Report Number: 1828100-2017-00583
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Other Device ID Number: GTIN: (01)00886799000687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1828100-01/09/18-001-C
• Patient Sequence Number: 1