MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Catalog Number 102956

Device Problems Decreased Pump Speed (1500); Infusion or Flow Problem (2964); Noise, Audible (3273)

Patient Problem Thrombosis (2100)

Event Date 08/11/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.This medwatch is reporting the cmag motor.The cmag console was reported under mfr report #3003306248-2018-00001 and the pump was reported under mfr.Report #2916596-2018-05008.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was being supported by an extracorporeal circulatory support pump.It was reported the ecmo machine started alarming and the centrimag (cmag) console was black.The pump still appeared to be running although it was making a humming noise.The patient was stable and blood was visualized flowing through the circuit.The backup cmag console was turned on and the flow probe was placed to confirm flow, with it operating at 1-1.5 liters lower than the desired 5 liters it had been flowing.The patient's family stated they heard a noise right before the machine started alarming and the humming began.Perfusion was called and the staff were advised to attach a monitor to see if they could manipulate the settings but unfortunately they were unable to change rpm's at the time.Once the monitor was attached, the error codes "set pump speed not reached m5, system alert s3" were displayed.Since the patient continued to remain stable, the decision was made to wait for perfusionist to come as there was concern of clot due to the sound the family heard and the noise the pump was making at the time.Perfusionist arrived and was unable to achieve the rpm's it was set at and the flow was dropping.The perfusionist was able to successfully switch to the backup pump and flows of 5 liters were achieved.The primed circuit that was brought was placed in the motor they had just replaced and the humming continued.After the above incident occurred, the clinical engineering staff at the account set up the cmag console with the accessories used in incident and ran for several hours with no errors.The system was left running overnight.Upon arrival in the morning the unit was alarming with blank screen and reduced flow rate.Flow was stopped and the display returned with s3 error "system error".A restart was attempted by increasing rpms but no flow occurred.M3 error "flow error" received.Rebooted unit and it again functioned without errors.

Manufacturer Narrative

Section f9: approximate age of device - 3 years 1 months (calculated from device manufacturer date).Manufacturer's investigation conclusion: during the investigations at thoratec switzerland gmbh (tsg), the reported faults were seen in the console¿s log-files, and the faulty behavior was also reproduced during intensive tests that were performed using engineering test equipment.The complaint was therefore confirmed.The tests revealed that a temporary cable defect had caused the multiple events at ¿rochester¿ hospital.An intermittent short circuit - which had most probably appeared as electrical sparks - had repeatedly occurred between a motor or bearing phase and broken copper wires of the motor cable¿s outer cable shield (which is connected to earth potential).The fault was/is intermittent.The motor may operate a certain time as intended.However, the fault will re-occur.Therefore, the defective motor was clearly marked with red stickers and stored in the quarantine area for 12 months; it will afterwards be scrapped.The returned console with flow probe operated as intended throughout the tests.Nevertheless, a preventive action was performed on the console: a new motor controller pcb with associated cable was assembled.Note: this preventive replacement action has already been performed before the complaint motor was received at tsg.Additionally, the console¿s damaged front overlay was replaced with a new one.The repaired console sn (b)(6) was finally subjected to the repair and maintenance procedure mp-0138-10, rev.04, together with the returned flow probe (b)(6).Both devices passed all tests and were sent back to the distribution center, from where they will be forwarded to the customer.The returned, most probably defective motor sn (b)(6) was scrapped respective clearly marked with red stickers and stored in the quarantine area for 12 months.A new motor was sent as replacement free of charge for the customer.Centrimag motor instructions for use instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.The 2nd generation centrimag system operating manual section 4-"warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10-"emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual section 12.1-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8117665
• MDR Text Key: 128881963
• Report Number: 2916596-2018-05009
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102956
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention