MAUDE Adverse Event Report: THORATEC CORPORATION CMAG BLOOD PUMP; Pump, blood, cardiopulmonary bypass, non-roller type

Model Number 102953

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Noise, Audible (3273)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that the centrimag patient was getting a computed tomography (ct) scan and after moving back onto their bed, the flow on the centrimag console was not reading a numerical flow, just three dashes.The circuit was examined for kinks, but no obvious kinks were found.Blood flow was confirmed by shining a light on the tubing and checking the motor/pump head for blood flow movement, which confirmed that there was blood flow.The flow sensor was verified to be positioned properly and fully closed.Flow probe connection to the console was verified to be tightly inserted in the centrimag.Despite these steps, no numerical flow reading was achieved.The patient's mean arterial pressure (map) had decreased from 66 to 58 and was holding steady at ~50mmhg, but they had also received a propofol bolus for moving on the ct table, and it was not decreasing.An additional specialist evaluated the situation and was concerned about a flow probe malfunction.The pump head then intermittently made a loud vibratory noise.It was thought that possibly it wasn't seated properly, so the specialists verified that the pump head was "seated" correctly in the motor.The noise from the pump head started to become more frequent but the patient still had stable vital signs.The patient was quickly returned to the cardiac care unit as the pump head began visibly vibrating.The flow, as measured from an ancillary extracorporeal membrane oxygenation (ecmo) device, was significantly reduced.Another flow probe from a non-abbott device was placed onto the centrimag circuit to confirm flow.The decision was made to change the circuit and console/motor system.The change out was uneventful.The console and pump head were secure for return to abbott.Several hours later in the morning, it was noted that the pump head had a large clot surrounding ~1/4 to 1/3 of the actual pump head "vanes".Related mfr: 2916596-2024-00240 related mfr: 2916596-2024-00242.Related mfr: 2916596-2024-00652.

Manufacturer Narrative

Patient information was requested, information not yet available.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: CMAG BLOOD PUMP
• Type of Device: Pump, blood, cardiopulmonary bypass, non-roller type
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 18596346
• MDR Text Key: 333972548
• Report Number: 2916596-2024-00241
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Lot Number: L08168-LA8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention