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

Model Number 6382

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the user facility, there was tubing in the flow sensor and the circuit was primed with lactated ringers.There were no backflow alarms and evidence of forward flow.The flow reading on the centrifugal controller was displayed as three dashes, and on the ccm the flow was flashing and would not change with changes in revolutions per minute (rpm).There were no tube clamps applied and the tubing was not installed in the venous occluder.No damage was noted to the flow sensor, cable or connector.In an attempt to resolve the issue, the biomedical technician (biomed) disconnected the interface module, plugged it back in and the flow reading was appropriate temporarily before the dashes and flashing flow reading appeared again.The field service representative (fsr) verified the reported complaint.He ordered a new flow sensor to be sent to the user facility.

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the flow display on the central control monitor (ccm) was flashing.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated block: device available for evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the flow sensor to function as intended throughout the evaluation.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: 7334426
• MDR Text Key: 102910641
• Report Number: 1828100-2018-00121
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• 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: 06/28/2018

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: Health Professional
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Other Device ID Number: GTIN: (01)00886799000083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 04/12/2018; 06/15/2018
• Supplement Dates FDA Received: 05/07/2018; 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FX 25 OXYGENATOR