MAUDE Adverse Event Report: CARDIACASSIST INC. TANDEMLUNG OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 5160-0000

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  malfunction  

Event Description

It was reported that when the patient was placed on the tandemlife oxygenator, support was initiated with flows of approximately 3 liters per minute, but shortly after initial flows began to drop to 1 liter per minute.Above 300 mmhg.Standard troubleshooting was performed, and the oxygenator pressure drop was elevated.The oxygenator was changed out and support was continued without issue with the new oxygenator.Device history review did not identify any deviations or non-conformities relevant to the reported issue.The device was received for product analysis.The returned device showed evidence of thrombus in the bundle, which may have developed during support or shipment from residual blood left in the device.The elevated pressure drop was consistent with what was reported by the site.The drop in flow was likely caused by thrombus developing in the fiber bundle.Sectioning the device showed deposits in the central fiber layers which were evidence of the presence of a thrombus.It was unclear if the thrombus had formed either during the case or from residual blood left in the device after the device was changed out and sent back for analysis.It was noted that thrombus layers in the center layers of fiber can have a large effect on the pressure drop.The root cause of the pressure drop was unable to be definitively determined, however it appeared likely that the presence of a thrombus in the oxygenator caused the flow issues reported during use of the device.No additional or relevant information has been received to date.

• Brand Name: TANDEMLUNG OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: njemile crawley ; 620 alpha drive; pittsburgh, PA 15238 ; 2812287200
• MDR Report Key: 8848805
• MDR Text Key: 163298912
• Report Number: 2531527-2019-00042
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2021
• Device Model Number: 5160-0000
• Device Catalogue Number: 5160-0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1