MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problems Infusion or Flow Problem (2964); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2019

Event Type  Injury  

Manufacturer Narrative

The cause of the event is unknown.Thus, the event is also reported under cmag motor (s/n: (b)(4)) and reported under mfr #2916596-2019-05098.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag (cmag) motor became noisy and juddered.The flow dropped and there was a damped circuit.The speed wouldn't increase.The cmag console was changed to backup cmag console.Low flow alarm sounded.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a low flow alarm was confirmed via the downloaded log file.The centrimag 2nd generation primary console (serial#: (b)(6) was returned for analysis to the edc belgium.A log file was downloaded from the returned console for review.A review of the downloaded log file showed events spanning approximately 117 days (on (b)(6) 2019, per time stamp).On (b)(6) 2019 at 14:19 the sub fault ¿sf_ifd_flow_below_min¿ activated and triggered a ¿flow below minimum: f3¿ alarm.At the same time, the sub faults ¿sf_lmc_drive_torque_saturated¿ and ¿sf_ifd_underspeed¿ and ¿sf_lmc_levitation¿ triggered ¿set pump speed not reached: m5¿ and ¿motor alarm: m4¿ alarms.At 14:20, a ¿motor stopped: m1¿ alarm activated.The returned console was evaluated and tested at the edc belgium.The console was visually inspected, and no anomalies were found.The battery was replaced due to the due date.The system was able to power on and pass the self-test as intended.The system functioned as intended and the reported event was unable to be reproduced.The console was tested with the returned and associated motor (serial#: (b)(6) and flow probe (serial#: (b)(6).The system was run for 10 days and no anomalies were found.Preventative maintenance and a safety test were performed per procedure.The root cause for the reported low flow alarm was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9262409
• MDR Text Key: 164496682
• Report Number: 2916596-2019-05097
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1