MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Inaccurate Flow Rate (1249); Decreased Pump Speed (1500)

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

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

The motor will be returned for evaluation once the temporary replacement is 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 rpms dropped from 5200 to 4950, but there was not any type of alarm for this.Half a liter of flow dropped but was within 1 liter range of the desired flow.The patient was asymptomatic.To troubleshoot, the clinicians changed out the motor but kept the same console, and the same issue occurred.Subsequently, the console was switched out and the issue was resolved.The patient was using the new motor and new console.The console was previously returned due to fluctuation in rpms and cannot stay in 5500 rpms.The product was returned but the engineers could not replicate the issue.

Manufacturer Narrative

Manufacturer's investigation conclusion for centrimag motor: no centrimag motor-related issues were reported and the motor was not returned for evaluation.It was reported that rpms dropped from 5200 to 4950, but there was not any type of alarm.Half a liter of flow dropped, but was within 1-liter range of the desired flow.The patient was asymptomatic.To troubleshoot, the clinicians changed out the motor but kept the same console, and the same issue occurred.Subsequently, the console was switched out and the issue was resolved.The patient was using the new motor and new console.The console was previously returned due to fluctuation in rpms and cannot stay in 5500 rpms.The console was previously returned but the engineers could not replicate the issue (see complaint (b)(4).Additional information was provided that the patient experienced a drop in pressure and rhythm changes.An onsite evaluation was performed by abbott representatives (see (b)(4).Upon the technical review of the centrimag equipment, in addition to the professional opinion of the hospital staff, it was concluded the problem was not due to centrimag system failure but rather a patient management problem.The excessive presence of blood clots could explain the behavior observed on the centrimag log files.The centrimag system operating manual states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support".Manufacturer's investigation conclusion for centrimag console: the reported event could not be confirmed; however; an onsite evaluation was performed by abbott representatives (see attached).Upon the technical review of the centrimag equipment, in addition to the professional opinion of the hospital staff, it was concluded the problem was not due to a centrimag system failure but rather a patient management problem.The excessive presence of blood clots could explain the behavior observed in the centrimag log files.It was reported that rpms dropped from 5200 to 4950, but there was not any type of alarm.Half a liter of flow dropped, but was within 1-liter range of the desired flow.The patient was asymptomatic.To troubleshoot, the clinicians changed out the motor but kept the same console, and the same issue occurred.Subsequently, the console was switched out and the issue was resolved.The patient was using the new motor and new console.The console was previously returned due to fluctuation in rpms and cannot stay in 5500 rpms.The console was previously returned but the engineers could not replicate the issue.Additional information was provided that the patient experienced a drop in pressure and rhythm changes.It was reported the console would not be returned for evaluation.Abbott¿s 2nd generation primary console operating manual states the recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console to continue patient support.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7855431
• MDR Text Key: 120109290
• Report Number: 2916596-2018-03627
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG 2NG GENERATION PRIMARY CONSOLE.
• Patient Age: 60 YR
• Patient Weight: 90