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

Model Number 102956

Device Problem Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2019

Event Type  Injury  

Manufacturer Narrative

This event is also reported against the centrimag console in mfr.Report #2916596-2019-05945.The patient's date of birth and age were not provided.The patient¿s gender was not provided.The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date are unknown.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that a patient was brought to the operating room and when transferred from one bed to the other, the console shut down.They were able to resume support with the backup system with little harm to the patient.When the biomed department tried to troubleshoot the device, they found nothing wrong.Additional information has been requested but not yet provided.

Manufacturer Narrative

Manufactures investigation conclusion: the centrimag devices associated with this event were not returned for analysis.Multiple requests for product return and additional information did not receive a response.As a result, the reported event could not be confirmed, and the root cause could not be conclusively determined.Per reported information, the customer was able to resume support with their backup system.The hospital's biomed department tried to troubleshoot the device and they found nothing wrong.Reports of similar events will continue to be tracked and monitored.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: 9483880
• MDR Text Key: 173932132
• Report Number: 2916596-2019-05963
• Device Sequence Number: 1
• Product Code: KFM
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50