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

Model Number 201-30105

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

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 there was a flow of 0.47 lpm when the centrimag (cmag) system was not turned on and there is no flow.The cmag flow probe was connected to a backup cmag system, and the problem continued.The flow probe was then switched with the a different flow probe with the same console.This resolved the issue.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the flow probe measuring flow when the motor isn¿t running was confirmed.The centrimag flow probe was returned for analysis to the edc and was evaluated.The reported event was able to be reproduced.The flow probe was tested with two different consoles.When the motor was not running, 0 rpm, the flow readings were always between 0.40 lpm ¿ 0.48 lpm.The flow probe is out of calibrations and will be scrapped.The root cause for the reported event was conclusively determined to be due to the flow probe needing calibration.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: EM-TEC PEDIATRIC 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: 9713050
• MDR Text Key: 180194600
• Report Number: 2916596-2020-00838
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

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: Lay User/Patient
• Device Model Number: 201-30105
• Device Catalogue Number: 201-30105
• Device Lot Number: 6480352
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1