MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR; KFM: CENTRIMAG MOTOR

Model Number 201-10002

Device Problems No Audible Alarm (1019); No Display/Image (1183)

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

Event Date 02/24/2014

Event Type  malfunction  

Event Description

The patient was supported with an acute blood pump system.It was reported that the pump flow values stopped displaying on the console.The hospital staff also reported that no audible and visual alarms were seen and it was unknown if the pump actually stopped.The perfusionist inspected the system and during the movement of the flow probe connector, the flow display and the speed display stopped; however, it was unconfirmed if the pump stopped.The perfusionist switched the patient to a backup console and no effects to the patient were reported.

Manufacturer Narrative

Usage of the device: the motor is not labeled for single use.The patient remains ongoing with pump support and no effects to the patient were reported.The motor was returned to the manufacturer for evaluation and is currently being analyzed.No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: KFM: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; zurich CH-8 005; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-8 005; SZ CH-8005
• Manufacturer Contact: robert fryc ; 23 fourth ave.; burlington, MA 01803 ; 7812720139
• MDR Report Key: 3813264
• MDR Text Key: 16089471
• Report Number: 2916596-2014-00450
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2014

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
• Device Lot Number: 400336
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2014
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR