MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE; PRIMARY CONSOLE WITH ADULT FLOW PROBE

Model Number 201-30105

Device Problems Decreased Pump Speed (1500); Pumping Stopped (1503)

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

Event Date 06/23/2019

Event Type  Injury  

Manufacturer Narrative

Motor = mfr# 2916596-2019-03234; console = mfr # 2916596-2019-03185.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that after approximately 45 minutes after initiation on va ecmo, a low flow alarm was triggered.When healthcare providers we looked at the screen, it said ¿no flow¿.Healthcare providers emergently did a pump change and restored the revolutions per minute(rpm) and flow measured in liters per minute(lpm) back to what they were before the no flow alert occurred.Healthcare providers weren¿t aware of anything that happened that would cause that sudden failure in flow.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of "no flow" and a speed reading of 0rpm was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console ((b)(6), evaluated under (b)(4)) associated with this event.Per the log file, the console was powered on at approximately 2:57pm on (b)(6) 2019 and the system was initially set to support a pump at a set speed of ~1900rpm and a flow rate of ~2.8lpm and the system operated without any issues.At approximately 3:11pm speed was adjusted to ~4200rpm and then increased to ~4400rpm.After this speed adjustment flow was captured at ~4.6lpm.At approximately 3:20pm the log file captured a momentary flow below minimum: f3 alert during which flow was captured at 0.007lpm.This resolved within 10 seconds.At ~3:31pm speed was increased to ~5000rpm and flow increased to ~5.5lpm.The system operated on ac power without any issues until approximately 4:03pm, when a shutdown event was captured.Following this event speed dropped to 0rpm and flow was measured at ~-1.0lpm and the console alarmed with motor disconnected:m2 and flow signal interrupted:f2 alerts.At ~4:04pm the pump was captured as disconnected and the console was powered down at ~4:10pm.The returned centrimag 2nd gen flow probe ((b)(6)) was evaluated and tested by the service depot.The reported complaint could not be verified during their evaluation.The flow probe was operated with its associated motor ((b)(6), evaluated under mfr#2916596-2019-03234) and 2nd gen primary console ((b)(6), evaluated under mfr#2916596-2019-03185).No flow issues were detected and no error alarms or any other issues were observed at any point.No flow probe related issues were observed during testing.As a result, the root cause of the reported event could not be conclusively determined nor correlated to a flow probe related issue.The tested device was returned to the customer site.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE
• Type of Device: PRIMARY CONSOLE WITH ADULT FLOW PROBE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8786383
• MDR Text Key: 150881821
• Report Number: 2916596-2019-03335
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: 07640135140108
• 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
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• 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: 07/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 35 YR
• Patient Weight: 88