MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; CENTRIFUGAL BLOOD PUMP

Catalog Number 102953

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

This medwatch is reporting the pump.The cmag console was reported under mfr report #3003306248-2018-00001 and the cmag motor was reported under mfr.Report #2916596-2018-05009.Serial number of pump was not provided.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

Manufactures investigation conclusion: the centrimag blood pump was not returned analysis.There was no correlation between the blood pump and the reported event.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: CENTRIFUGAL BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8117631
• MDR Text Key: 128860758
• Report Number: 2916596-2018-05008
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention