MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH MAG MONITOR SET; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90404

Device Problems No Display/Image (1183); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

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

There was a mag monitor that had a white screen when connected.The monitor was sent in for repair, a loaner was not requested at the time.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag monitor displaying a blank white screen was confirmed.The returned centrimag monitor (serial number (b)(6) was functionally tested at mcs zurich and at mcs burlington, and the reported event was reproduced upon powering the monitor on.The monitor¿s housing was opened, and it was observed that the connector of the lcd cable was not properly connected to the lcd pcb.The cable was reconnected properly and the monitor was retested.After the reconnection, the monitor operated as intended, and atypical events were unable to be further reproduced.A full functional checkout was performed, and the monitor was returned to the customer site after passing all tests per procedure.The root cause of the reported event was a loose lcd cable within the monitor¿s housing.The most probable cause of the loose connection was that the lcd cable had not been properly connected during the manufacturing process and became looser during its usage time in the field, as the monitor passed required manufacturer testing at mcs zurich on (b)(6)2016 before being shipped to the distributor.This issue is continuing to be tracked and monitored.A loose lcd cable within the centrimag monitor is a known issue and the production staff was reinstructed and retrained on (b)(6)2018.Centrimag monitor (b)(6) was assembled before this retraining occurred.In addition, two other production staff members, which also assemble mag monitors at mcs zurich, were also re-instructed/re-trained in order to prevent future occurrences of loose lcd cables.The device history records for centrimag monitor (b)(6) were reviewed.The monitor passed all required testing at mcs zurich on (b)(6)2016 before being shipped to the distributor.The mag monitor is an optional accessory for easy handling of the 2nd generation system, however it is not necessary for the system to function.The 2nd generation centrimag system operating manual section 4-"warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: MAG MONITOR SET
• 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: 10487858
• MDR Text Key: 205874715
• Report Number: 2916596-2020-04135
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140696
• UDI-Public: 07640135140696
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 201-90404
• Device Catalogue Number: 201-90404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1