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

Model Number 201-30300

Device Problems Pumping Stopped (1503); Vibration (1674); Noise, Audible (3273)

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

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of the device is 3 days.The patient remains on centrimag support with no further issues reported.

Event Description

It was reported that the patient was on 3700 rpms and flow was 3.4 lpm and stable.At 12:45am the centrimag motor started to make a humming noise and clinician placed her hand on the motor and felt a much stronger vibration than normal.Alarm flow below minimum sounded and then the lpm appeared to be dashes.The rpm dropped suddenly from 3700 to 3200 rpm.The console screen blanked out even though the monitor still was on showing rpm at 3200 and dashes on lpm.Clinician attempted to raised the rpms on monitor with no response.The nurse called out for assistance and then initiated an emergency system exchange to the backup system.The total exchange time from initial alarm to reinitiating of flow to the backup system took 45 seconds.

Manufacturer Narrative

Sections b1, d4, e3, e4, h4: additional information.Sections d10, h1, h3: correction.Manufacturer's investigation conclusion: the reported event of a humming noise from the motor was not confirmed; however, the reported event of blank console display and a drop in speed was confirmed.The centrimag 2nd generation primary console was returned for analysis.A log file was downloaded from the console.A review of the downloaded log file showed events spanning approximately 12 days ((b)(6) 2019 ¿ (b)(6) 2019 per time stamp).The console was operating the motor at a speed of ~3700 rpm with a flow ~3.4 lpm.On (b)(6) 2019 at 06:46, the sub fault ¿sf_ifd_shutdown_detected¿ activated and triggered the alarms ¿system alert: s3¿ and ¿flow signal interrupted: f2¿.The speed dropped to ~3200 rpm.The ¿motor disconnected: m2¿ alarm activated in the same time stamp as well.The motor and flow dropped to 0 rpm and 0 lpm respectively.The alarms were able to be muted and cleared.The console was forwarded to the service depot for analysis.The returned console was evaluated and tested.The reported event was unable to be reproduced.The console was run for an extended period of time with a test motor and with the returned and associated motor and flow probe.No alarms or issues with the flow or the screen, occurred at any time.The console functioned as intended.A successful battery maintenance was performed.Per field action ¿fa-q318-mcs-1¿ (see mfr.Report number 2916596-2019-02513), it was confirmed that the new backup system warning label was present on the back of the console.Reports of similar events have been documented and corrective action had been initiated to investigate the issue further.The investigation has determined that the issue is not related to a 2nd generation primary console related issue.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.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 8647138
• MDR Text Key: 146273797
• Report Number: 2916596-2019-02514
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 115