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 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The srt observed that when the flow-meter had a flow set to five liters per minute (l/min) and the output was 0 voltage direct current (vdc).Srt replaced the flowmeter.The unit operates to the manufacturer's specifications.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, there was no output from the flow meter to the electronic patient gas system (epgs) pod.There was no patient involvement.

Manufacturer Narrative

Please disregard the reference in the previous submission.Further information was received that determined this complaint was not related to the referenced recall.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 that the flowmeter was producing incorrect voltages.The flowmeter was installed into a lab use only electronic patient gas system (epgs) and connected to a system 1 simulator.Oxygen (o2) and air were attached at 50 pounds per square inch (psi).After the 15-minute warmup period, calibration of the epgs was initiated and failed.The pst measured the output voltage of the flowmeter at 0 liters per minute (l/min) and 5 l/min flow rates.At 0 l/min, the output voltage was 1.3 volts and at 5 l/min, the output voltage was 3.86.Voltages were compared to the lab use epgs¿s flowmeter and at 0 l/min the output voltage was 0.0 volts and at 5 l/min the output voltage was 2.5.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.The manufacturer's supplier has determined that the device was damaged from an unknown cause.The lead was broken off the differential pressure sensor.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: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7499650
• MDR Text Key: 107827080
• Report Number: 1828100-2018-00258
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• 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: 05/29/2019

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/11/2018; 08/17/2018; 04/17/2019; 05/20/2019
• Supplement Dates FDA Received: 06/05/2018; 09/07/2018; 04/17/2019; 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-04/08/19-002-C
• Patient Sequence Number: 1