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

Model Number 102956

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

No patient involved.Approximate age of device cannot be calculated due to missing serial number.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It as reported that the centrimag motor was not working.The device was returning for evaluation.

Manufacturer Narrative

Adverse event, single use device?, concomitant medical products, device manufacture date, usage of device: additional information.Device evaluated by mfr: corrections.Manufacturer's investigation conclusion: the reported event of the pump rattling was confirmed.The reported event of console not working is confirmed via the console investigation.The centrimag motor was returned for analysis with a bent set screw on the locking ring of the motor.The motor underwent resistance and insulation testing.During resistance testing of the motor cable, an open loop was noted in line a2 (a2+/a2-) when the motor cable was bent near the motor body end.The motor cable passed insulation testing.The pump rattled when the motor was operated with a test system.The centrimag motor was forwarded to the service depot for analysis.The returned motor was evaluated and tested under work order #53696915.The service depot was able to verify and duplicate the reported event.The pump head began to rattle when the motor cable was bent slightly near the motor end.The root cause for the pump rattling was conclusively determined to be due to the damage to the set screw on the motor as well as the motor cable damage.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 CH-80 05; SZ CH-8005
• MDR Report Key: 8514972
• MDR Text Key: 141954900
• Report Number: 2916596-2019-01457
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

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: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1