MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Catalog Number 201-90411

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

There was no patient involved the event happened during device setup.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that a centrimag 2nd generation primary console had blown fuses.The led to the ac power was out and the fuse was blown.The fuse was changed out and it blew out again.The unit was not in use on a patient at the time of the event.The unit was sent in for repair.No further information was provided.

Manufacturer Narrative

Manufacturer name, city and state: correction.

Manufacturer Narrative

Investigation summary: the report of a centrimag 2nd gen primary console blowing fuses was confirmed and reproduced during testing of the returned centrimag 2nd gen primary console.The console was evaluated and tested at mcs zurich.The returned console was connected to ac power but the console's ac power led did not flash.When the console was switched on it started up on battery power (the green battery led was flashing; the ac power led did not flash).The fuses of the (ac) power entry module were inspected and one fuse was found to be missing.The remaining fuse was checked with a multi-meter and was not defective.The missing fuse was replaced with a new one.However, it became defective as soon as the console was connected to ac power, reproducing the reported event.Further testing found that the console's 24v power supply printed circuit board (pcb) was defective.However, due to this pcb being a part from an external supplier ("fsp power solutions gmbh"), no schematics were available at mcs zurich and no further investigation on the component level could be performed.As a result, the root cause of the 24v power supply pcb being defective could not be conclusively determined.The defective pcb and fuse were replaced with new components.Additionally, the console's battery pack was replaced due to having expired.The repaired console was functionally tested and functioned as intended after the repair.The serviced and tested console was returned to the customer site.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8122719
• MDR Text Key: 129022185
• Report Number: 2916596-2018-04749
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1