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

Model Number 102956

Device Problem Pumping Stopped (1503)

Patient Problem Right Ventricular Failure (2055)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Implant date: the date of implant was not provided.Approximate age of device ¿ the motor is not a single use device.The age of the device is unknown.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support pump on (b)(6) 2019.It was reported that on (b)(6) 2019, when the screw on the centrimag motor was at 3 o'clock and the outflow was at 6 o'clock, the pump shut off.

Event Description

Additional information: the patient had end stage heart disease with severe right systemic ventricular dysfunction.The fundamental diagnosis was hypoplastic left heart syndrome (hlhs).The lvad device was explanted during an orthotopic heart transplantation (oht) on (b)(6) 2019.The oht was reported to not be related to the device or device therapy, the vad was operating as expected.

Manufacturer Narrative

Sections b5, b7, h3, h4: additional information.Sections d3, g1: correction.Section d4: the centrimag motor is a reusable device and therefore does not have an expiration date.This motor was manufactured before the generation of a udi for the device, therefore one has not been included in this report.Section f9: approximate age of device - 8 years 4 months (calculated from the manufactured date).Manufacturers investigation conclusion: the reported event of a pump stop regarding the centrimag motor was confirmed.The returned centrimag motor (serial number (b)(6)) was tested on 21jun2019.The complaint was verified ¿ a connection failures in the cable was found when manipulating the cord at the motor¿s end.The pump was reported to have stopped immediately.The cable failed for conductor breakdown and the unit will be scrapped.The root cause of the pump stop was conductor breakdown within the motor¿s cable.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; technoparkstrasse 1; zurich, CA CH-80-05 ; SZ CH-8005 ; 781858204
• MDR Report Key: 8607911
• MDR Text Key: 144973574
• Report Number: 2916596-2019-02129
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• 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: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 10 MO
• Patient Sex: Male
• Patient Weight: 8 KG