MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30105

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

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

It was reported that the centrimag console alarmed battery module fail twice and the alarm hasn't repeated.The doctor was at the bedside when this happened and elected not to change the console.It was reported it was advised to keep a backup available and not transport the patient without being informed.The battery indicator shows 3.45h and the console has been plugged in the entire time.The rpms were 3800 with 4.5 l/min flow.No adverse event reported, and no additional information reported.

Manufacturer Narrative

No further information was provided.

Manufacturer Narrative

Manufacturing investigation conclusion: the reported event of damage to the flow probe was confirmed.The centrimag flow probe (serial #: (b)(6) was returned for analysis and was evaluated and tested under work order: 54176585.The flow probe was tested and functioned as intended.Damage observed to the flow probe cable, exposing the shielding underneath; however, there was no damage to any underlying wires.The flow probe was connected to a test centrimag system and always functioned as intended.The root cause for the damage was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: EM-TEC ADULT FLOW PROBE
• 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: 9690044
• MDR Text Key: 179791704
• Report Number: 2916596-2020-00526
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30105
• Device Catalogue Number: 201-30105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 04/24/2020
• Supplement Dates FDA Received: 03/06/2020; 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 90