MAUDE Adverse Event Report: THORATEC CENTRI-MAG 34 FR. DRAINAGE CATHETER; CANNULA

Catalog Number 201-50067

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Blood Loss (2597)

Event Date 07/19/2015

Event Type  Injury  

Event Description

A (b)(6) male transferred from another facility with cardiogenic shock/respiratory failure on (b)(6) 2015 who was placed on va ecmo, then transitioned to bivad centri-mag with removal of ecmo/iabp on (b)(6).By (b)(6) his condition had improved and bivad explant was planned.At 10:22am rn responded immediately to call by patient's wife who had just removed the patient from the bedpan.The nurse noted a large amount of blood in the sheets and lvad inflow cannula that was disconnected; the tubing was immediately reconnected.(b)(6) at bedside clamped both rvad and lvad outflow.Faps dropped.Lij double central line was inserted and prbc's administered.Lvad team changed the dislodged cannula tubing with resumption of blood flow.Patient developed monoclonic movements and head ct was performed which showed hemorrhagic conversion of old pca infarct; likely representing diffuse hypoxic brain injury due to either hypotension or new air emboli.Examination of tubing after the showed a crack.

• Brand Name: CENTRI-MAG 34 FR. DRAINAGE CATHETER
• Type of Device: CANNULA
• Manufacturer (Section D): THORATEC; 6035 stonebridge drive; pleasanton CA 94588
• MDR Report Key: 5168178
• MDR Text Key: 28985966
• Report Number: 5168178
• Device Sequence Number: 1
• Product Code: KFM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201-50067
• Device Lot Number: 201411055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2015
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR