MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

Device Problem Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

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 the gen 2 centrimag (cmag) was unable to power on with ac power.The unit is running only on dc power.He said he has tried a new ac power cord with no changes.The fuses were blown at first.Centrimag in question sent to thoratec for repair.Centrimag loaner had been put in place of unit until repair was complete.No patient involvement, problem was discovered during daily inspection.

Manufacturer Narrative

Section d4: no expiration date is known.Expiration date was reported incorrectly in the initial report.Sections d10, h3, h6 (patient code): corrected data.Section h4: additional information.Manufacturer's investigation conclusion: the report of a centrimag 2nd gen primary console not being able to power on while on ac power was confirmed and reproduced during testing of the returned centrimag 2nd gen primary console (sn: (b)(6) was evaluated and tested by the service depot.The reported complaint was confirmed during their evaluation.The unit was then forwarded to mcs zurich for further testing and repair.At mcs zurich the returned unit was connected to ac power and powered on.However, only the green battery led on the console's front panel was flashing, the green ac-power led remained dark.Because the console operated on battery power, it alerted with a "on battery:b6" message, as designed.The returned console did not operate on ac power, confirming the reported event.During further evaluation it was noted that the console's two fuses were damaged.The damaged fuses were replaced with new ones and the console was reconnected to ac power.This caused the two new fuses to became damaged as well.The console was disconnected and opened so that its internal components could be evaluated.With the ac power cord connected to the console, measurements of the power supply pcb revealed that although 230v ac was available at the power supply's input while the output voltage was 0v dc, instead of the expected 24v dc.Even when all loads were removed from the power supply's output, the output voltage remained at 0v dc.Based on previous complaint experience, the power supply was determined to be the most probably cause of the issue and was replaced with a new one.Once the damaged power supply was replaced, the observed issue resolved and the repaired console operated as intended.The root cause of the power supply becoming damaged could not be conclusively determined during the investigation.The 24v power supply pcb is an externally supplied part.Due to the damaged pcb being over 4 years old it was noted to have passed its warranty and no scar was opened.The console's internal battery pack was replaced with a new one.The repaired console passed functional testing using laboratory test equipment and was found to function as intended.The repaired and tested console was returned to the customer site.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 9715562
• MDR Text Key: 179620001
• Report Number: 2916596-2020-00513
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: IFS101676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention