MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE

Catalog Number 201-30300

Device Problem Device Stops Intermittently (1599)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

The patient's age, gender and weight were not provided.The primary console is not a single use device.Approximate age of the device is 15 days (calculated from the manufacture date of the primary console).The devices are expected to be returned for analysis.They have not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on biventricular extracorporeal circulatory support.It was reported that an m6 alarm appeared on the primary console screen.An interruption in support occurred.It was reported that the patient experienced unspecified symptoms and harm due to the event.After the primary console and motor were quickly exchanged, the patient continued with biventricular support.No additional information was provided.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; thoratec switzerland gmbh; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7401922
• MDR Text Key: 104533129
• Report Number: 2916596-2018-01274
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2018

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 Catalogue Number: 201-30300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MOTOR: (B)(4 ,
• Patient Outcome(s): Hospitalization; Required Intervention