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

Model Number 201-30300

Device Problems Fluid/Blood Leak (1250); No Flow (2991)

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

Event Date 07/28/2019

Event Type  Injury  

Manufacturer Narrative

The console is not a single-use device.The age is unknown.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a centrimag extracorporeal circulatory support system.It was reported that both the primary console and the backup console both registered zero flow.No alarms were reported.The healthcare team assumed that the pump was not spinning at this time, although this was not visually confirmed.The primary console reportedly displayed the normal pump speed and it was possible to change the pump speed on the console.The console and motor were exchanged.There was reportedly no indication of a clot or other impediment to flow that may cause a no flow reading.The healthcare team reportedly believes this issue to be related to a cannulation issue that resulted in a brief flow cessation that corrected itself while the system was being exchanged.The healthcare team reported an identical issue with the same patient that was resolved with manipulation of the patient's neck and cannula.Reportedly, the patient is particularly susceptible to positional changes in flow through the cannulae.The healthcare provider also reported that there had been a leakage current detected on the centrimag cart three hours prior to the event, but it was reportedly felt that the issue had been identified and the culprit device, a multi-socket power board, was removed.Upon inspection, the power board appeared to have been damaged by fluid ingress prior to use.No other equipment was affected by the current leakage.The centrimag system was not able to be tested after the current leakage and before being placed on a patient.No further information was provided.

Manufacturer Narrative

Section b5, d10, h4: additional information.Manufacturer's investigation conclusions: the centrimag 2nd gen primary console (sn (b)(6)) was not returned for analysis.As a result, the reported event could not confirmed and the root cause could not be conclusively determined.Per reported information, the customer suspected that the event was caused by a cannulation issue.The customer also reported that they were unable to reproduce any fault in the units (both console and motor) after the event.They also reported that an identical issue occurred with the same patient in which manipulation of the patient's neck and cannula remedied the problem and flow resumed.This patient was reported to be particularly susceptible to positional changes in flow through the cannulae.Finally, it was reported that nobody actually confirmed that the pump was not spinning by visual inspection, but that it was felt that was the case based on the sudden drop of flow to zero.After the event occurred support was switched to a backup system and there were no further issue nor consequences to the patient.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual (doc.(b)(4)) section 10-"emergency and troubleshooting" 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.Do not exchange individual motors or individual consoles during patient support." no further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: the hospital was able to isolate the cause of this issue to factors outside the centrimag.The console and motor are still in use at the hospital and there have been no further issues reported with this equipment.No further information was provided.

Manufacturer Narrative

Correction to g1.

• 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: 8905914
• MDR Text Key: 154728041
• Report Number: 2916596-2019-03899
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1