MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

The event is also reported in cmag console under mfr #2916596-2019-05625.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the motor was reportedly not being recognized with the console and showed motor disconnect alarm.No patient was involved with this event.According to additional information provided, the motor was swapped out but the alarm did not resolve.No further information was provided.

Manufacturer Narrative

Section h3: although the customer stated that the product would be returned for evaluation, no product has been received to date.Multiple attempts were made to obtain product return information but this information was not provided.Additional information.Manufacturer's investigation conclusion: the reported event of a m2 alarm was not confirmed.The centrimag motor (serial #: (b)(6) was not returned for analysis.No log files or photos were submitted for review.The root cause for the reported event was not conclusively determined through this analysis.\no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9395351
• MDR Text Key: 168637143
• Report Number: 2916596-2019-05624
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1