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

Model Number 201-10002

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for analysis.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that during the in-service performed at the hospital, the motor was not being recognized when the primary console was turned on.Turning the primary console off and on, and disconnecting and reconnecting the motor did not resolve the issue.When the motor cable was moved a little bit, the primary console stopped alarming.The alarm disappeared after clearing the alarm.The motor was exchanged for a device that had no problem at all.No patient was involved with the event.No additional information was provided.

Manufacturer Narrative

Section h1: correction.Section g1: correction.Manufacturers investigation conclusion: the report of the centrimag motor not being recognized by a console was confirmed and reproduced during testing of returned centrimag motor (serial number (b)(6)).The returned motor was evaluated and tested.The reported complaint was verified and reproduced during testing.The motor was connected to a test 2nd gen primary console and flow probe.Upon booting up the console the motor immediately produced a motor disconnected:m2 alarm.However, after attempting to set pump speed and start the pump the console alarmed with a pump speed not set: m4 alarm.The motor's cable was inspected per field action "fa-q318-mcs-1".Additional testing of the motor's cable revealed intermittent open connections in both the drive (a1, b1) and bearing (a2, b2) connections when the motor's cable was manipulated at both the motor end and console connector ends.Although the root cause of this damage could not be conclusively determined, it appeared consistent with conductor breakdown due to repetitive bending or twisting of the motor's cable during use.The defective motor 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.

• 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: 8355956
• MDR Text Key: 136788879
• Report Number: 2916596-2019-00581
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 201-10002
• Device Catalogue Number: 201-10002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1