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

Model Number 802112

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The user facility tried another cable but the problem remained so they continued the procedure without it.They were unable to pull the sensor out because the unit would reconfigure.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the pressure module would not zero.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) was unable to duplicate the reported complaint.The pressure module operated as intended throughout the evaluation.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2018 at 3:26 am, both channels of the pressure module are zeroed successfully.Channel 1 and channel 2 offset were -19 which is in line with previous calibrations.The sensors are disconnected at 7:25 am and the system is power cycled.Both pressure channels are zeroed again with the same offset.At 10:26 am, channel 1 starts reporting 'pressure under range'.The sensor is disconnected and reconnected.When attempts are made to zero the sensor the offset is -250 now.After several attempts the offset returns to -15 at 10:50 am.At 10:54 am channel 1 starts reporting 'under range/in range'.At 10:57 am the module reports 'ch1 / ch2 out of h/w range' error and enters broken mode.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: 7488074
• MDR Text Key: 107920974
• Report Number: 1828100-2018-00243
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802112
• Device Catalogue Number: 802112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1