MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

Device Problems Device Difficult to Setup or Prepare (1487); Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Date 03/14/2023

Event Type  Injury  

Event Description

It was reported that during transport, the console had an audible alarm which indicated that the motor was not connected.It was observed that the pump was making sound indicative of it not being properly seated.Once the patient arrived from the transferring hospital and the patient was moved to their unit, switched pump to new motor and console, experienced same issue.Ultimately it was decided to switch the pump out, the patient was stable immediately after the process.During the process the patient received a large amount of epinephrine prior to changing the cone to increase output and pressure.After the cone was changed, the epinephrine caused the patient to have ventricular tachycardia but came out of it with no intervention.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

E1: reporter email not available.The patient was transferred to (b)(6).Manufacturer's investigation conclusion: the evaluation was unable to confirm the report of a sound indicative of the pump not being properly seated in the motor, and a specific cause for the event was unable to be conclusively determined through this evaluation.The centrimag blood pump, lot number l07746-la1, was returned with two cut pieces of tubing connected to the inlet and outlet ports.No abnormalities or depositions were discovered in the tubing, inlet port, nor outlet port.Examination of the pump housing revealed no depositions or thrombus formations.The pump housing showed no evidence of abnormal scratching or other damage.No abnormal impressions were observed next to the four grooves on the periphery of the blood pump.Examination of the impeller portion of the pump rotor revealed no evidence of depositions, thrombus formations, or damage.The rotor blades revealed no evidence of abrasion or damage.Examination of the rotor base and rotor well revealed no evidence of depositions or thrombus formations.The rotor base showed no evidence of abrasion or other damage.The rotor well revealed no evidence of abnormal scratching or other damage.There was no evidence of separation or slippage between the rotor magnet and rotor body.Following cleaning, the blood pump was functionally tested on a mock circulatory loop with a test motor and equipment.The blood pump functioned as intended in accordance with manufacturing specification.No noise, rattling, or grinding was reproduced.The centrimag pump (lot: l07746-la1) was sent to a different abbott site for measurement.The measurements revealed that all three dimensions of the pump housing geometry, interacting with the locking mechanism of the motor, are within the specifications.The pump could be inserted into two test motors without problems.The device history record for centrimag blood pump lot #l07746-la1 was reviewed and showed no deviations from manufacturing or quality assurance specifications.The united states (us) centrimag blood pump instructions for use (ifu) list warnings and cautions regarding the use of the centrimag circulatory support system: ifu warning #17: frequent patient and device monitoring is recommended.Ifu caution #11: run the pump only on a properly maintained console and motor.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled ¿pump setup and operation¿ provides instructions for how to mount the blood pump on the motor.The following instructions are provided: to mount the pump on the motor, remove the pump from the inner tray and insert the pump into the motor receptacle.Place the bottom of the pump into the motor receptacle with the outlet port positioned in the large groove.Match the grooves on the periphery of the pump with the fittings on the motor receptacle.Rotate the pump counterclockwise until the pump locks securely into place.Thread the retaining screw clockwise to secure in place.The pump must be fully seated into the receptacle to function properly.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• 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: 16683640
• MDR Text Key: 312776945
• Report Number: 3003306248-2023-01382
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• 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,Followup,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L07746-LA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 79 KG