MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-10002

Device Problem No Display/Image (1183)

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

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

The motor is not a single use device.The approximate age of the device from the date of manufacture to the date of the event was 1 year and 3 months.The event occurred at (b)(6) hospital, (b)(6).Manufacturer's investigation conclusions: the reported event of a blank display and a speed drop was confirmed via the log file.The centrimag motor (serial #: (b)(4)) was returned for analysis and was investigated.The reported event of a blank display and a speed drop was able to be confirmed via the log file; however, it was not able to be reproduced.A log file was downloaded from the returned and associated console (serial #: (b)(4)), investigated under (b)(4).A review of the downloaded log file showed an ifd-shutdown (display dark) sub fault active on (b)(6) 2019 at 17:48.The sub fault triggered a ¿system alert: s3¿ and a ¿set pump speed not reached: m5¿alarms.The speed dropped from 5000 rpm (flow of 5.4lpm) to 3270 rpm with 0 lpm of flow displayed.A further investigation on the returned devices was performed by the r&d department.Although the reported event could not be reproduced, reports of similar events have been documented and corrective action had been initiated to investigate the issue.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.

Event Description

The patient was implanted with a centrimag extracorporeal circulatory support system on an unspecified date.It was reported that on (b)(6) 2019, the console went blank while still in use on the patient.The monitor still read 3000 rpm but did not read any flow on the flow probe.The speed had been 5000 rpm and dropped to 3000 rpm without any actions from the operators.An emergency pump exchange was performed.When this was done, the original primary console was noted to be functional again.No further information was provided.

Manufacturer Narrative

The device returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

Manufacturer Narrative

Section d3, g2: corrections.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8896372
• MDR Text Key: 154403589
• Report Number: 2916596-2019-04003
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

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: 201-10002
• Device Catalogue Number: 201-10002
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/08/2019; 02/10/2020
• Supplement Dates FDA Received: 09/04/2019; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention