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

Model Number 201-30100

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

The cause of the event is unknown.This event is also reported on cmag motor under mfr #2916596-2019-05050.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 centrimag (cmag) console 1st generation does not show the flow parameter during maintenance check.The issue continued even when the console was connected to a different motor.The console was replaced.There was no issue with the cmag motor which was used with a different console for troubleshooting purpose.

Manufacturer Narrative

Section d10, h3, h4: additional information.Manufacturer's investigation conclusions: the reported event of the console not displaying the flow parameter during the maintenance check was not confirmed.The centrimag 1st generation primary console (serial #: (b)(6) was returned for analysis and was evaluated.The console returned with a damaged lcd.The 1st generation centrimag consoles are unable to be repaired and the console was subsequently scrapped, and no further testing was performed.The root cause for the reported event was not conclusively determined through this analysis; however, the observed damage to the lcd may have contributed to the reported event.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: 9304316
• MDR Text Key: 166369582
• Report Number: 2916596-2019-05020
• 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
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1