MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE; PRIMARY CONSOLE

Model Number 201-30100

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) # (device identifier): device was manufactured prior to the udi labeling implementation.The primary console is not a single use device.Approximate age of the device is 9 years, 4 months (calculated from the manufacture date of the primary console).The event occurred at (b)(6).The report of a system shutdown was confirmed and reproduced during testing of the returned primary console.The console was powered on and a ¿system fault¿ message was displayed on the display screen.The console would not operate a motor.The console was disassembled and a connection p3 (bsm power) was observed to be disconnected.The connector was connected to the main printed circuit board connector.The console was re-assembled and powered on without any issues.The console was tested along with the returned motor and flow probe, as well as a test pump and mock circulatory loop, and the system was operated for several days at different speeds and as well as stress tested at 5500rpm (flow of approximately 3.0lpm) without any issues being observed.The root cause of the reported issue was determined to be the disconnected p3 connector.The root cause of this connector being disconnected could not be conclusively determined during the investigation.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.

Event Description

It was reported that on (b)(6) 2018, after cardiotomy surgery and inability to wean from the extracorporeal circuit (ecc), centrimag support was initiated.After implant, the pump stopped during transfer of the patient to the intensive care unit while on battery transportation.The primary console displayed zeros instead of values for the flow range and pump speed.All connections and contacts were checked and were fine.Immediately after pump stoppage occurred, the battery indicated a full charge and then showed a full discharge.When attempting to start the pump several times, it did not resume the flow.The main primary console was replaced with a backup primary console.No additional information was provided.

• Brand Name: PRIM CONS 1ST GEN, STANDALONE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8295594
• MDR Text Key: 134699789
• Report Number: 2916596-2019-00379
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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: 06/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 124