MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90150

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that during use of the centrimag system for circulatory support the primary console did not show flow measurement.The clinical team changed the flow probe from the backup unit and there was still no blood flow displayed on the primary console.The clinical team then changed the centrimag primary console to the centrimag backup console.After the console was exchanged the flow measurement was immediately displayed.The clinical team checked both flow probes on the working backup console with proper function.Because of this, the suspected malfunction origin was the centrimag primary console.The unit was taken out of use.The patient did not experience any adverse consequences.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental finding: damaged housing.The reported event of the console not showing flow was not confirmed.The centrimag 1st generation primary console was returned for analysis to the edc and was evaluated and tested.The console booted up as intended and was tested for 24 hours at a speed of 5000 rpm and a flow of ~9 lpm and functioned as intended.The console was tested for another 24 hours at a speed of 1000 rpm with a flow of ~1.5 lpm and functioned as intended.The reported event was not able to be reproduced during testing; however, the console was scrapped due to the damaged housing.The root cause for the reported event was not conclusively determined through this analysis.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PRIM CONS 1ST GEN, STANDALONE
• 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: 9909997
• MDR Text Key: 189325901
• Report Number: 3003306248-2020-00017
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1