MAUDE Adverse Event Report: CARDIACASSIST INC TANDEMHEART PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 5120-0000

Device Problem No Flow (2991)

Patient Problem Low Cardiac Output (2501)

Event Date 12/14/2018

Event Type  malfunction  

Event Description

The patient was cannulated with an avalon cannula connected to a tandemheart circuit.The avalon cannula was noted to be deep on insertion, but given that the team was cannulating at an off-site hospital the decision was made to leave it deep as they were still able to achieve adequate flows ~ 4.2 l/min.Overnight the cannula was noted to be positional so the next day the decision was made to withdraw the cannula slightly.Approximately 15 minutes prior to prepping the patient, the perfusionist had begun hemoconcentrating to remove fluid, but said he was having difficulty removing fluid, even with the clamps wide open and back pressure applied.After prepping, the sutures were cut and the cannula was only very slightly moved.After this very slight movement, the flows on the circuit quickly dropped to 2 l/min then 0.5 l/min then 0 l/min.The perfusionist attempted to adjust the rpms in case this was a suck-down event but flows stayed at 0 l/min.No air was noted to enter the circuit.After seconds of no flow the patient began to decompensate and the decision was made to emergently switch over to the rotaflow circuit.After switching circuits the patient stabilized.The tandem circuit was saved for inspection.Customer is uncertain of etiology of flow reduction.The device has been received however analysis has not been completed to date.

Event Description

A review of the manufacturing records for the pump revealed there were no device issues noted during testing prior to distribution.

Event Description

Analysis was completed on the returned pump.During analysis, the pump was in specification and functioning normally.There was a thrombus noted in the upper housing of the pump that could have contributed to a drop in flow however it is unclear if the thrombus developed during use or during return for analysis.Since no issue was found with the pump, the exact cause of the drop in flow is unknown.

• Brand Name: TANDEMHEART PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): CARDIACASSIST INC; 620 alpha drive; pittsburg PA 15238
• MDR Report Key: 8235480
• MDR Text Key: 132994976
• Report Number: 2531527-2019-00012
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K110493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 5120-0000
• Device Catalogue Number: 5120-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention