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

Model Number	195240
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's sales representative, the adhesion was fine but when the user facility tried to lock the red or yellow sensor on to the pad, the metal sensor pushed the pad off the reservoir.The level sensors were not used.
Event or Problem Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads were not functioning properly.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
H3: 81 evaluation is in progress, but not yet concluded.Per the sales associate, the level sensor pad would not stick to the surface even after they waited for a few minutes before connecting the level sensor to the pad.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) was not able to duplicate the reported issue.The pst observed the pads adhering well to the lab use only reservoir in ambient and cold temperatures.He used significant finger lifting force, but could not remove the pads attached.He also tried to use a flat head screwdriver to pop the pads from the reservoir which was very difficult to pop off.All nine of the pads were used.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 10214753
• Report Number: 1828100-2020-00238
• Device Sequence Number: 2404677
• Product Code: DTQ
• UDI-Device Identifier: 10886799001704
• UDI-Public: (01)10886799001704(17)211130(10)918264
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K022947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 08/07/2020; 09/08/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/22/2020; 08/28/2020; 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1