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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Thrombus (2101); No Code Available (3191)

Event Date 02/05/2018

Event Type  Injury  

Event Description

It was reported that a thrombus was observed in the circuit and it was decided to replace the tandemlife equipment with another circuit system.During the change out, the patient¿s mean arterial pressure was in the 20s when the patient went into pulseless electrical activity (pea) arrest.The patient was then given epinephrine and the issue resolved without sequelae.The physician assessed the event as related to the removal procedure for the tandemlife products.No additional relevant information has been received to date.

Event Description

The patient¿s age and gender were provided.No additional, relevant information has been received to date.

Event Description

Information was received that the circuit was changed due to drainage in the venous connector having a clot.It was noted that an additional tubing connector was added in order to provide additional length.The manufacturing records for the last 10 pumps sent to the site before the date of the event were reviewed as the serial number of the device was unknown.No deviations or non-conformities relevant to the reported issue were noted.No additional 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
• MDR Report Key: 8664935
• MDR Text Key: 146890744
• Report Number: 2531527-2019-00036
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR