MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE; DWA: CENTRIMAG PRIMARY CONSOLE

Model Number 102954

Device Problems Decreased Pump Speed (1500); Use of Device Problem (1670); Low Battery (2584)

Patient Problem Syncope (1610)

Event Date 10/16/2014

Event Type  Injury  

Event Description

The patient was being supported with a ventricular assist device for acute support.The patient was walking around with nurses for about 2 hours on the unit's battery power when suddenly the pump stopped and the console shut off.The nurses were reportedly aware of the console's low battery condition, and they were trying to get the patient to the bed prior to the pump stoppage.When the pump stopped, the patient fell forward to the ground.The patient is scheduled for a ct scan and chest x-ray.After the event, the vad coordinator did state that the pump in use during the event was charged over night.The console indicated that the battery was fully charged and appears to be functioning.No error message is present.The center will put the console back into service.The patient is doing well after the incident.

Manufacturer Narrative

Usage of the device: the usage of the primary console is not known to the manufacturer as the device is not labeled for single use.To date, the serial number has not been provided from the hospital.The approximate age of the device is unknown.The device remains in use at the hospital.No further information is available at this time.A supplemental report will be submitted when the device analysis is completed.

Manufacturer Narrative

A device-related root cause for the reported event could not be verified through this evaluation as the cmag primary console was not returned to thoratec for evaluation; however, the account communicated that the hospital staff were aware of the console's low battery condition and were trying to get the patient to bed prior to the pump stoppage.No further information is available.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: DWA: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; zurich CH-8 005; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588 CH-
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 7812720139
• MDR Report Key: 4253070
• MDR Text Key: 4991902
• Report Number: 2916596-2014-02065
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 11/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 82