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

Catalog Number 201-30100

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

Patient Problem Cardiac Arrest (1762)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

The serial number of the device was requested but was not provided, therefore the manufacture date, device unique identifier (udi) and age of device are unknown the device is expected to be returned for evaluation.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 was being supported with an extracorporeal circulatory support pump.It was reported that the centrimag (cmag) primary console had a battery failure that caused a momentary pump stop.The event occurred when the patient was transported for a ct.After 15-20 minutes of being unplugged from ac power, rpms suddenly dropped to 0 and the primary console alarmed ¿battery malfunction¿.There were no other alarms prior to the event.The primary console was plugged back into ac power; however, rpms remained at 0 with message of ¿battery malfunction¿.The pump and motor were then switched to the backup console and the pump resumed.At the time of the pump stop, the patient¿s condition worsened and the patient arrested, but was resuscitated.The patient was stabilized after the pump stoppage and remained on support for several weeks.Per the patient¿s wishes, care was withdrawn on an unspecified date and the patient expired.No further information was provided.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• Manufacturer (Section G): THORATEC CORPORATION; thoratec switzerland gmbh; technoparkstrasse 1; ch-8005 zurich ; SZ
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7312954
• MDR Text Key: 101494121
• Report Number: 2916596-2018-00844
• 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
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201-30100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening
• Patient Age: 42 YR
• Patient Weight: 68