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

Model Number L102956

Device Problems Pumping Stopped (1503); Vibration (1674); Noise, Audible (3273)

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

Event Date 05/23/2019

Event Type  Injury  

Event Description

It was reported that the patient was on 3700 rpms and flow was 3.4 lpm and stable.At 12:45am the centrimag motor started to make a humming noise and clinician placed her hand on the motor and felt a much stronger vibration than normal.Alarm flow below minimum sounded and then the lpm appeared to be dashes.The rpm dropped suddenly from 3700 to 3200 rpm.The console screen blanked out even though the monitor still was on showing rpm at 3200 and dashes on lpm.Clinician attempted to raised the rpms on monitor with no response.

Manufacturer Narrative

Section h9: the device returned for analysis.The complaint investigation determined the reported event was the result of a software design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.Manufacturer's investigation conclusion: the reported event of a humming noise from the motor was not confirmed; however, the reported event of blank console display and a drop in speed was confirmed.The centrimag motor was returned for analysis in unremarkable condition.A log file was downloaded from the returned and associated console.A review of the downloaded log file showed events spanning approximately 12 days (b)(6) 2019 ¿ (b)(6) 2019 per time stamp).The console was operating the motor at a speed of ~3700 rpm with a flow ~3.4 lpm.On (b)(6) 2019 at 06:46, the sub fault ¿sf_ifd_shutdown_detected¿ activated and triggered the alarms ¿system alert: s3¿ and ¿flow signal interrupted: f2¿.The speed dropped to ~3200 rpm.The ¿motor disconnected: m2¿ alarm activated in the same time stamp as well.The motor and flow dropped to 0 rpm and 0 lpm respectively.The alarms were able to be muted and cleared.The motor underwent resistance and insulation testing on the motor cable and passed.The motor was tested on a test console and no humming from the motor was observed.Final disposition of the motors will be determined by the capa.Reports of similar events will continue to be tracked and monitored.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8647117
• MDR Text Key: 146271878
• Report Number: 2916596-2019-02513
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 115