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

Model Number 201-30100

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cardiac Arrest (1762); Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2019

Event Type  Injury  

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 the nurse noticed reduced flow on the console, which was followed by complete motor failure.There was no blood flow through the device.The patient experienced desaturation/peri-arrest for 20 to 30 seconds while the healthcare team exchanged the console and motor.Blood flow was restarted once the system was exchanged.No further information was provided.

Event Description

Related manufacturer report number: 3003306248-2020-00020.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of reduced flow followed by the system stopping was not confirmed.The returned centrimag console (serial number (b)(6)) was tested by the european distribution center and by the ppe department.The console was connected to the returned centrimag motor (serial number (b)(6)), was found to perform as intended.The motor was set to various speeds, and the observed flow value correlated accordingly.The reported event of the motor stopping was unable to be reproduced.Although the console operated as intended, the console was observed to have various damages upon arrival and had a dull, flickering display.Since 1st generation centrimag consoles are no longer able to be fully repaired, the console was scrapped per procedure.The root cause of the reported event was unable to be determined through this analysis.Section 9.3, entitled ¿recommended preventive maintenance¿ within the centrimag primary console operating manual instructs users regularly inspect the condition of the centrimag console, and to return to the console for servicing if any damage is observed.Section 10, entitled "emergency/trouble shooting" of the centrimag 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.Do not exchange individual motors or individual consoles during patient support." review of the device history record for centrimag primary console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.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: 10020361
• MDR Text Key: 193305896
• Report Number: 3003306248-2020-00019
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30100
• Device Catalogue Number: 201-30100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US
• Patient Outcome(s): Required Intervention