MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30105

Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182)

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

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ the centrimag primary console is not a single use device.Approximate age of the device from the manufacturer date is 1 year 5 months.The device was returned for investigation.The evaluation is not yet complete.Console, mfr# 2916596-2019-02528.Motor, mfr# 2916596-2019-02529.Flow probe, mfr# 2916596-2019-02712.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 with a ventricular assist device (vad) for acute support.It was reported that the patient was placed on support on (b)(6) 2019 as va (vein-artery) extracorporeal membrane oxygenation (ecmo) with rpm 5500 flow 4.8 lpm.The patient was converted to vv (vein-vein) ecmo a few hours later and maintained 5500 rpm and 4.5 lpm.The pump motor started making a louder than normal humming sound, it became physically slightly hot, & rpms.On (b)(6) 2019, system alert s3 alarm came on and dashes appeared on the lpm.Rpm dropped to 3900 rpm and set pump speed not reached alarm m5 appeared.The patient circuit & physical pump was changed at bedside.The customer clamped the circuit and rebooted the system and reinitiated support.The set speed of 5500 dropped to 4900 rpm with dashes on lpm and the system alert s3 appeared.The customer switched to backup system and resumed support.It was determined by biomed & the perfusion department that the centrimag motor was exhausted due to the large amount of resistance induced by a very small outflow cannula size (15 fr), given that the rpm was maxed out at 5500 rpm, and the patient was very large ((b)(6) kg).Equipment was exchanged, disposables including centrimag changed, & eventual reduction of rpms and removal from ecmo support.Patient successfully removed from ecmo support on (b)(6) 2019.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of a system alert: s3 alarm and a set pump speed not reach: m5 alarm were not reproduced when the returned centrimag flow probe (serial number (b)(6) was tested.The centrimag flow probe was inspected under a work order alongside the centrimag 2nd gen.Primary console (serial number (b)(6), the centrimag motor (serial number (b)(6), and the centrimag monitor (serial number (b)(6).The reported events of s3 and m5 alarms were not reproduced during testing, and no other errors were observed.The flow probe functioned as intended, and as a result, the root cause of the reported event could not be correlated to an issue with the flow probe.The flow probe was returned to the customer site.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE
• 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: 8697220
• MDR Text Key: 148000945
• Report Number: 2916596-2019-02712
• 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,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30105
• Device Catalogue Number: 201-30105
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 145