MAUDE Adverse Event Report: THORATEC CORP. CENTRIMAG MOTOR

Model Number 201-10002

Device Problems No Display/Image (1183); Failure to Pump (1502)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

The patient was supported with an acute blood pump system.It was reported that upon re-initiation of therapy, after an oxygenator change-out, the hosp team attempted to increase the pump speed; however, the pump speed was not increasing or displaying, the flow was not displayed and the pump did not start.An audio alarm was heard but not displayed on the primary console.The motor and the primary console were switched out.

Manufacturer Narrative

The patient remains on pump support.The motor, primary console (serial # (b)(4)) and flow probe (serial # (b)(4)) were returned to the mfr for eval and are currently being analyzed.No further info is available at this time.A supplemental report will be submitted when the mfr's investigation is completed.

• Brand Name: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC CORP.; zurich CH-8 005
• 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: 4054329
• MDR Text Key: 4864706
• Report Number: 2916596-2014-01506
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/23/2014

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2014
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2006
• 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: 46 YR