MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 201-10002

Device Problems Device Stops Intermittently (1599); Power Problem (3010)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) # (device identifier): device was manufactured prior to the udi labeling implementation.The motor is not a single use device.Approximate age of the device is 9 years, 7 months (calculated from the manufacture date of the motor).The devices are expected to be returned for analysis.They have not yet been received.The event occurred at (b)(6) hospital, (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that on (b)(6) 2018, after cardiotomy surgery and inability to wean from the extracorporeal circuit (ecc), centrimag support was initiated.After implant, the pump stopped during transfer of the patient to the intensive care unit while on battery transportation.The primary console displayed zeros instead of values for the flow range and pump speed.All connections and contacts were checked and were fine.Immediately after pump stoppage occurred, the battery indicated a full charge and then showed a full discharge.When attempting to start the pump several times, it did not resume the flow.The main primary console was replaced with a backup primary console.No additional information was provided.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich 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 ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7481680
• MDR Text Key: 107186600
• Report Number: 2916596-2018-01622
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: BU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201-10002
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention