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

Model Number 5120-0000

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

Patient Problems Infarction, Cerebral (1771); Death (1802); Paralysis (1997)

Event Date 01/24/2018

Event Type  Death  

Event Description

It was reported that the patient developed a right hemiplegia due to a left basal ganglia infarct.Labs were performed and were positive for a heparin induced thrombocytopenia.The physician suspected a possible clot in the circuit.The tandem heart pump, transseptal cannula and femoral arterial canula were exchanged for new components.The physician thought the issue was related to the tandem heart devices.The pump that was exchanged has not been received by the manufacturer to date.No additional relevant information has been received to date.

Manufacturer Narrative

Corrected data: supplemental mdr # 03 inadvertently did not include the date the patient passed away.

Event Description

The patient passed away on (b)(6) 2018.

Manufacturer Narrative

Outcomes attributed to adverse event (check all that apply), corrected data: initial report inadvertently did not indicate the death of the patient.Describe event or problem, corrected data: information inadvertently did not include information about the death of the patient.Type of reportable event, corrected data: initial report inadvertently did not indicate the death of the patient.Patient codes, corrected data: initial report inadvertently did not include coding for the death of the patient.

Event Description

It was reported that after tandemlife the system had been replaced the patient¿s family signed a dnr.Life support was then withdrawn and the patient subsequently passed away.Information was later received from the physician that the root cause of the stroke and subsequent death in its relationship to the tandemlife equipment is unknown.The event had been initially reported at the initial report (2018) however at that time the physician did not believe the tandemlife device caused or contributed to the patient¿s poor outcome.However information was received in 2019 where the physician stated that it was possible that the events were related to the device but could not be definitely determined by the physician.

Event Description

Incoming communication was received that identified patient age and gender at the time of the event.No further relevant information has been received to date.

Event Description

A review of the manufacturing records for the pump and cannulas involved did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: TANDEMHEART PUMP
• Type of Device: NON-ROLLER TYPE BLOOD PUMP
• Manufacturer (Section D): CARDIACASSIST INC.; 640 alpha drive; pittsburgh PA 15238
• MDR Report Key: 8329443
• MDR Text Key: 135847435
• Report Number: 2531527-2019-00022
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5120-0000
• Device Catalogue Number: 5120-0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/18/2019; 04/24/2019; 07/31/2019; 09/05/2019
• Supplement Dates FDA Received: 02/27/2019; 05/21/2019; 08/22/2019; 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 72 YR