MAUDE Adverse Event Report: CARDIACASSIST INC. TANDEMHEART PUMP; NON-ROLLER TYPE BLOOD PUMP

Model Number 5120-0000

Device Problem Failure to Pump (1502)

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

Event Date 01/23/2020

Event Type  malfunction  

Event Description

It was reported that within minutes of beginning support the perfusionist reported that the flow dropped from 4l to 2l and eventually 0l while the patient was on the or table.The pump and oxygenator were exchanged.Device history records were reviewed for the returned pump and oxygenator.Both were reviewed and no conformities or abnormalities were found.The pump and oxygenator were received by the manufacturer for product analysis.When the pump was returned a thrombus was evident on the impeller vanes and the current draw values were higher than specified, potentially due to the thrombus observed.It cannot be determined whether the thrombus was present during use in the field, or whether it was a result of return shipping conditions.During internal visual inspection of the pump lower housing and journal bores, particulate was found which may indicate improper priming of the pump during use.The drop in flow was likely due to an increased resistance of the oxygenator due to thrombus formation.No further relevant information has been received to date.

• Brand Name: TANDEMHEART PUMP
• Type of Device: NON-ROLLER TYPE BLOOD PUMP
• 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 street; pittsburgh, PA 15238 ; 2812287200
• MDR Report Key: 9820087
• MDR Text Key: 188700470
• Report Number: 2531527-2020-00014
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 5120-0000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1