MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Decreased Pump Speed (1500); Failure to Align (2522)

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

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Patient information requested, not provided.Approximate age of device will be submitted when the manufacturer's investigation is completed.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was placed on the centrimag device on (b)(6) 2019.It was reported that the patient was stable in the icu on centrimag lvad at approximately 3100 rpm when the system lost lpm flow and dashes appeared on the monitor and console.The following alarms occurred: m5, s3, f2.The ecmo manger attempted to disconnect and reconnect the flow probe.That did not correct the problem.At that time the patient went asystolic and the pump stopped.The clinician initiated emergency system exchange to the backup system however they were unable to get the pump seated properly in the new system so they shut the original pump off and restarted to see if the motor would restart.The original system did restart and cleared all the alarms so they re-initiated support on the same original system.Once the patient was stabilized the hcp did not want to switch the patient on another system in fear of the patient's condition as too fragile and unstable.The customer was waiting to get the approval to switch the patient to another system and then return the console, motor and monitor for investigation of the failure.Additional information has been requested, but not been provided.

Manufacturer Narrative

The device returned for analysis.Similar reports has been investigated and the reported event was the result of a software design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott will perform a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The investigation will be submitted as a follow-up once it is complete.

Manufacturer Narrative

Section d3: correction sections d4, h3, h4: additional information manufacturer's investigation conclsuion: the reported event of blank flow and s3, f2, and m5 alarms was confirmed.The centrimag motor serial #: (b)(6) was returned for analysis.The motor cable underwent resistance and insulation testing and passed.The motor was run on a test centrimag system and functioned as intended.A log file was downloaded.A review of the downloaded log file showed events spanning approximately 14 days (16may19 ¿ 30may19 per time stamp).The console was operating a motor at a speed of ~4800 rpm with a flow of ~4.5 lpm prior to the reported event.On 17may19 at 10:51, the sub fault ¿sf_ifd_shutdown_detected¿ which triggered the alarms ¿system alert: s3¿ and ¿set pump speed not reached: m5¿.The speed dropped to ~3300 rpm and no flow was displayed.The alarms were able to be muted.The m5 alarm was able to be cleared.An additional photo submitted by the customer showed the reported event on the centrimag mag monitor.Although the reported event was not reproduced, reports of similar events have been documented and corrective action has been initiated to investigate the issue further.The investigation has determined that this event was caused by a motor related issue.Final disposition of the motors will be determined by the capa.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.

Manufacturer Narrative

Section h6: correction to device code.The site was unable to provide additional information regarding the event, including whether the returned motor was the backup motor or the motor used at the time of the event.Based on the information provided, as well as the investigation findings, the motor that was not returned for analysis is assumed to be the motor that was unable to be seated properly and is reported under mfr #2916596-2019-02537.The motor that returned for analysis is assumed to be the motor that was used at the time of the event and produced the alarms and will be reported under this mfr (# 2916596-2019-02554).No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8664192
• MDR Text Key: 146845574
• Report Number: 2916596-2019-02554
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention