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

Catalog Number 201-90411

Device Problems Failure to Charge (1085); Low Battery (2584); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device - the centrimag primary console is not a single use device.The approximate age of the device from the date of manufacture is 4 years and 1 month.No further information was provided.A supplemental report will be submitted when the manufacturer's' investigation is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support device.It was reported that the patient was being transported from the operating room to the intensive care unit, and that the device had been set at the maximum speed to achieve the highest possible flows.It was reported that the battery charge indicator changed from 6 hours to 1.75 hours when battery support was initiated for transport.The battery was quick to discharge thereafter.The perfusionist was able to transport the patient to the recovery room by plugging the console into outlets for a short period of time en route.It was reported that the device flows remained stable during the transport.Upon arrival in the recovery room, the console was plugged into ac power; however, the battery indicator light did not immediately indicate the unit was charging.As a precaution the patient was placed on the backup console.No patient harm was reported.No additional information was provided.

Manufacturer Narrative

The console was not returned to the manufacturer for evaluation.A direct correlation between the device and the reported reduced battery support time and inability for the battery to recharge could not be conclusively determined.Based on the information received at the time of the event, the patient was placed on the backup console with no issue.Several unsuccessful attempts were made to obtain additional information from the customer.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich 8005 ; SZ 8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6661128
• MDR Text Key: 78384029
• Report Number: 2916596-2017-01299
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 201-90411
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2013
• 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 Age: 65 YR
• Patient Weight: 90