MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EMTEC PEDIATRIC FLOW PROBE, OUS; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90701

Device Problems Nonstandard Device (1420); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

The event was created against centrimag 2nd generation primary console ((b)(4)) and centrimag motor ((b)(4)); however these devices were never returned for evaluation (reported under mfr # 2916596-2019-01126 and 2916596-2019-01128.Instead centrimag 2nd generation primary console ((b)(4)) and centrimag motor ((b)(4)) were returned under this event without any information.Abbott made the decision on august 8, 2019 to initiate a voluntary recall, therefore, this event is being reported as the manufacturer's investigation of the centrimag 2nd generation primary console ((b)(4)) revealed the returned console to be a part of the corrective and preventative action that lead to the voluntary recall.No further information was provided.Manufacturer investigation conclusion: the returned centrimag 2nd gen primary console (sn (b)(4), evaluated under (b)(4)) and motor (sn (b)(4), evaluated under (b)(4)) were evaluated and tested by mcs (b)(4) under (b)(4).A data log file was retrieved from the returned centrimag 2nd gen primary console (sn (b)(4), evaluated under (b)(4)).Per the log file, console operation started on (b)(6) 2019 at 3:28pm.The console was first operating at a speed of ~3150rpm and a flow of ~7lpm.At approximately 10:10am on (b)(6) 2019 speed was adjusted to ~3500rpm and flow was measured at ~7lpm.At 12:20pm on (b)(6) 2019 speed was set to 0rpm by the user.No issues were captured in the retrieved log file.The reported event date of (b)(6) 2019 was not captured in the log file as newer events have overwritten older events.As a result, the reported issue could not be confirmed through the log file analysis.Testing of the returned 2nd gen primary console (sn (b)(4), evaluated under (b)(4)) and motor (sn (b)(4), evaluated under (b)(4)) was performed by the r&d department of mcs (b)(4).It was determined that the console operated as intended.No fault was found on the returned console.However, during testing a short circuit was produced by mistake of the investigator.The short circuit caused a defect on the ifd printed circuit board (pcb).Therefore, the damaged ifd pcb was replaced with a new one.Additionally, because the front overlay was scratched, it was replaced with a new one.A missing pouch and history card were also replaced with new ones.After the repair action, the console was subjected to the repair and maintenance procedure (mp-0138-10, rev.04) and it passed all tests.The tested console was finally returned to the distribution center to be forwarded to the customer.R&d investigation of the motor determined that it was responsible for the event in the field and the fault was reproduced in the lab.Corrective action was opened to handle the motor issue root cause investigation.Because the motor was heavily stressed during the investigation, it was not reworked but was scrapped.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 after 8 days of ecmo, an m4 alarm appeared.No pump stop.After some minutes, monitor of the console became dark.Healthcare professional changed the console and the motor drive with a back up system.No further information was provided.No further information was provided.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EMTEC PEDIATRIC FLOW PROBE, OUS
• 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: 8983931
• MDR Text Key: 159518813
• Report Number: 2916596-2019-04327
• 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: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/10/2020
• 2 Devices were Involved in the Event: 1 2

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: 201-90701
• Device Catalogue Number: 201-90701
• Device Lot Number: 6310877
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1