MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

The associated centrimag 2nd generation primary console, sn: (b)(4) is reported under mfr # 2916596-2020-00891, and the associated centrimag motor, ous, sn: (b)(4) is reported under mfr # 2916596-2020-00892.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

It was reported that there was an s3 alert on the console while the system was in use on a patient in an ambulance en-route to the hospital.There was also no flow probe reading.The back-up console was attached and initially got a reading.However, then the same s3 alert appeared and the flow probe did not have a reading.The device was detached from the ambulance power supply and turned off and on.Following that the flow probe worked fine for the duration of the journey.There were no adverse patient effects.No further information was provided.

Manufacturer Narrative

Section d10: additional information.Sections d4, h4: the device serial number was requested but was not provided, and therefore no expiration or manufacture dates are available.Manufacturer's investigation conclusions: the reported event of an s3 alarm occurring on the backup centrimag console was not confirmed.The backup centrimag console (serial number unknown) was not returned for analysis, and no log files regarding the console were provided.Per additional information, details regarding the console were unable to be obtained.The root cause of the reported event was unable to be determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9748445
• MDR Text Key: 182996121
• Report Number: 2916596-2020-00893
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140894
• UDI-Public: 7640135140894
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1