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

Model Number 102956

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that a m4 error code was observed.There was no patient involvement reported.No additional information was provided.

Manufacturer Narrative

Additional information investigation summary: the reported event of a m4 error code was confirmed.The centrimag motor (serial #: (b)(4) was returned to the service depot for analysis.The returned centrimag motor was evaluated and tested under work order # (b)(4).The service depot ran the returned motor with a test console and immediately received a m2 and m4 motor connector error.Ppe investigated the returned motor and found an intermittent open connection in the cable in phase a2+/a2-.The intermittent connection is coincident with the motor errors received by the service depot.The performed tests meet the requirements set per field action ¿fa-q318-mcs-1¿ of an inspection of the motor cable.The root cause for the reported m4 error code and the observed m2 error code was conclusively determined to be due to the intermittent connection in the motor cable in phase a2+/a2-.No further information was provided.The manufacturer is closing the file on the event.

Manufacturer Narrative

Corrected data no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• 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: 8307705
• MDR Text Key: 137024028
• Report Number: 2916596-2019-00392
• Device Sequence Number: 1
• Product Code: KFM
• 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,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• 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