MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; CENTRIFUGAL BLOOD PUMP

Model Number 102953

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Align (2522)

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

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device will be submitted when the manufacturer's investigation is completed.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was place on the centrimag device on (b)(6) 2019.It was reported that the patient was stable in the icu on centrimag lvad at approximately 3100 rpm when the system lost lpm flow and dashes appeared on the monitor and console.The following alarms occurred: m5, s3, f2.The ecmo manger attempted to disconnect and reconnect the flow probe.That did not correct the problem.At that time the patient went asystolic and the pump stopped.The clinician initiated emergency system exchange to the backup system however they were unable to get the pump seated properly in the new system so they shut the original pump off and restarted to see if the motor would restart.The original system did restart and cleared all the alarms so they re-initiated support on the same original system.Once the patient was stabilized the hcp did not want to switch the patient on another system in fear of the patient's condition as too fragile and unstable.The customer was waiting to get the approval to switch the patient to another system and then return the console, motor and monitor for investigation of the failure.Additional information has been requested, but not been provided.

Manufacturer Narrative

The serial number of the blood pump is unknown, therefore the manufacturing date, expiration date, and approximate age of device are unknown.Manufacturer's investigation conclusion: the reported event of being unable to get the pump seated properly in the new system was not confirmed.The centrimag blood pump was not returned for analysis and no log files or additional information was submitted for review.The root cause for being unable to get the pump seated properly in the new system was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: CENTRIFUGAL BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8664246
• MDR Text Key: 146906005
• Report Number: 2916596-2019-02555
• 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,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention