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

Model Number 201-90411

Device Problem Infusion or Flow Problem (2964)

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

Event Date 04/18/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age or date of birth, sex and weight: patient information not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

During patient support the centrimag experienced a significant decreased in flow.Prior to the event the flow was noted to be 4400 rpm with 5.8 lpm.After 40 mins of use the flow decreased to 1.1 lpm.The site stated there was no chatter or suck down.The patient's fluid balance remained positive.No kinking or abnormal cannula position were noted during troubleshooting.Two small clots were seen pre-oxygenator and some fibrin streaking post oxygenator.The account reported good color change.The patients spo2 dropped to 70% when the flow decreased.The motor did not appear to be warm or make any abnormal noise.The site swapped the centrimag circuit.After the exchange, the flow and spo2 levels increased.Upon visual inspection, there were no clots in the pump.Some clots were seen in the oxygenator.No further information was reported.Related manufacturer's report number: 2916596-2020-02392.

Manufacturer Narrative

Manufacturer investigation conclusion: the reported reduction in flow and active flow below minimum alerts could not be confirmed through this evaluation as no console log file data from the time of the reported event is available for review.A specific cause for the reported low flow issue could not be determined nor correlated to a device-related issue as no product was returned for analysis.It was reported that during patient ecmo support using the centrimag system, there was a significant decrease in flow on (b)(6)2020.No changes were made to the system; however, within 40 minutes system flow reduced from 5.8 lpm to 1.0 lpm, resulting in an active flow below minimum alert.The motor was reportedly not hot or making noise and there were no other active alarms besides the flow below minimum alert.The entire ecmo circuit was exchanged and flow was subsequently restored to 5.5 lpm at a pump speed of 4200 rpm while the patient¿s spo2 also returned to 100 percent.Upon inspection of the exchanged circuit, no clots were observed in the blood pump.It was noted that the oxygenator had some clotting; however, the circuit had been sitting for a few minutes with no flow, so it was difficult to determine whether the clotting was present prior to the circuit change or a result of blood coagulation afterward.The center stated that the flow issue did not appear to have been a pump failure.The ecmo lines were reportedly inspected prior to the occurrence and no clots were visible in the tubing.Multiple attempts were made to obtain information from the customer regarding whether any centrimag product would be returned for evaluation; however, no additional information was provided and no product has been returned to date.The centrimag 2nd generation primary console, serial number (b)(6), is not available for investigation.The device history record (dhr cpc2 l03258-0010) was reviewed and showed that the console was manufactured in accordance with manufacturing and quality assurance specifications.The centrimag 2nd gen primary console, serial number (b)(6), was shipped on 19jun2014.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.The 2nd generation centrimag system operating manual (document pl-0047, rev.11) contains the following information: section 4 ¿warnings & precautions¿: one additional centrimag console, motor and flow probe are required as backup components in the immediate vicinity of each patient whenever the centrimag or pedimag 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.Section 10 ¿emergency/troubleshooting¿: the recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the pump from the malfunctioning motor and console and place the pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support.Section 10.1 ¿10.1 switching to backup hardware¿: a backup console, motor and flow probe should be transported with the patient and immediately available for use at all times.Should the main console or motor cease to function, it will be necessary to replace the hardware by disconnecting the pump from the main motor and console and switching to a backup motor and backup console.Switch all components (console, motor, flow probe and cables) simultaneously and then perform troubleshooting on the non-functioning system when it is no longer being used for patient support.The operating manual provides a table describing all 2nd generation centrimag primary console alarms and alerts, as well as the system status and appropriate operator response associated with each alarm/alert condition.In the event of a f3 flow below minimum (low flow) alert, the following system status and operator response is provided: check for physiologic cause or circuit obstruction, check minimum flow set point.Do not increase rpm without confirming adequate blood volume is available, and common cause of this alert is inadequate blood volume at the drainage cannula site for the desired pump flow.The centrimag blood pump ifu contains the following additional warnings and cautions: ifu warning #9: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #14: do not operate the pump for more than 30 seconds in the absence of flow.The temperature within the pump will rise and increased cellular damage and clotting may result.Ifu warning #21: use of this pump for periods longer than durations appropriate to cardiopulmonary bypass procedures may result in pump failure, reduced pumping capacity, excessive blood trauma, degradation of blood contact materials with possibility of particles passing through the blood circuit to the patient, leaks, and increased potential for gaseous emboli.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a spare centrimag blood pump, back-up console, and equipment available for change out.The centrimag motor ifu cautions the user to always have a spare centrimag motor and back-up equipment available (ifu caution #9).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: 10023006
• MDR Text Key: 189983793
• Report Number: 2916596-2020-02396
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1