MAUDE Adverse Event Report: CARDIACASSIST INC. PROTEK DUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 5140-4629

Device Problems Insufficient Flow or Under Infusion (2182); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Death (1802)

Event Date 11/12/2019

Event Type  Death  

Manufacturer Narrative

Voluntary medical device correction (remedial action) was initiated by the manufacturer via physician notification letter.

Event Description

A report was received that an incorrect cannula was included in a tandemlife kit during use with a patient.During patient¿s care (patient was reportedly in poor condition upon arrival at facility), the planned use of one device (protek duo kit) was abandoned due to the patient¿s worsening condition (drop in blood pressure from 80 to ~50).Customer opened a tandemlife kit due to their need for use of oxygenator, which is included in the tandemlife kit.The pump and oxygenator was primed as normal, and the 17fr arterial cannula was placed in the right femoral artery.Instead of protek 24fr venous cannula being present in the kit, the protek duo29fr was present and used in the right femoral vein.Flows were reportedly low at 2-2.3l/min at 6,000rpm, as the circuit pulled from the distal port of the 29frprotek duo.Troubleshooting for low flow was attempted by increasing the rpms; however, customer was unable to increase the flows.Patient later expired, due to cardiogenic shock and metabolic acidosis.The device history records for each individual cannula and the overall kit was reviewed.Of the tandemlife kits (p/n 5740-2417) , 11 were built with 29 fr protekduo cannulas instead of 24 fr venous cannulas under two manufacturing orders, apr19096 and apr19121.No non-conformances were identified within the dhrs of the individual cannulas involved.Based on the poor condition of the patient prior to intervention with the tandemlife kit, the incorrect cannula and subsequent low flow are not believed to have caused the patient¿s death, but it's contribution has not been ruled out.The devices involved are not expected to be returned by the site.Attempts to the physician for clarifying information on the relationship between the incorrect cannula/low flow and the patient¿s death have been made.No additional relevant information has been received to date.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: njemile crawley ; 620 alpha drive; pittsburgh, PA 15238 ; 2812287200
• MDR Report Key: 9453962
• MDR Text Key: 170340301
• Report Number: 2531527-2019-00055
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: 215497
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2531527-12/4/2019-001-CR
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 170