MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG PRIMARY CONSOLE

Catalog Number 102954

Device Problems Display or Visual Feedback Problem (1184); Pumping Stopped (1503); Battery Problem (2885)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device: the centrimag primary console is not a single use device.Approximate age of the device from manufacture date is 4 years and 11 months.The device is expected to be returned for analysis.It has 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 is being supported with an extracorporeal circulatory support device.It was reported that when the patient was being transported after a ct scan back to the intensive care unit the primary console supporting the right ventricle alarmed with a low battery alarm and then the unit stopped.The health care professionals switched the extracorporeal circuit and motor to the backup console and support was resumed.During the event the patient's blood pressure dropped and there was no flow from the right ventricle; however there was no reported adverse sequelae.It was reported that "the low battery event was a malfunction." the console indicated ''battery below minimum'', but the battery gauge showed a full charge.

Manufacturer Narrative

Device evaluation: the reported event was confirmed during the evaluation of the returned device.The primary console was charged for 24 hours upon return.Approximately 10 minutes into the battery discharge test, the console displayed the battery below minimum alarm and stopped operating the pump.The internal battery was examined and was close to its expiration date, suggesting that it no longer provided enough battery power to operate the system.Once a new battery was installed, a battery maintenance was performed and the primary console passed the functional checkout without issue.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: 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 SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5241442
• MDR Text Key: 31784930
• Report Number: 2916596-2015-02179
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102954
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 84