MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L201-90411

Device Problems Mechanical Problem (1384); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2019

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

The site reported a centrimag presenting with alarm of "battery failure." the account changed pump and console.The locking screw were reported to not be properly threaded on back of pump.The patient was switched to a second back up pump.The centrimag pump was clamped twice prior to switch.The patient tolerated the equipment swap well.No further information was reported.

Manufacturer Narrative

Manufacturer"s investigator conclusion: the reported event of a battery failure was not confirmed.The centrimag 2nd generation primary console was not returned for analysis.No log files or additional information regarding the console was received.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

User facility report: (b)(4) was received (b)(6) 2019.Section a: multiple attempts were made to obtain additional information from the customer regarding patient identifier and weight; however, no additional information was provided.Section e4, f, h4, h5, h8: correction.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 9369088
• MDR Text Key: 167835862
• Report Number: 2916596-2019-05341
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2019,03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: L201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Report to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 02/10/2020; 03/03/2020; 03/25/2020
• Supplement Dates FDA Received: 02/27/2020; 03/23/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR