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

Model Number 102956

Device Problems Fitting Problem (2183); Connection Problem (2900)

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

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device, age of device is calculated from device manufacture date.Manufacture date is unknown until investigation is completed, therefore age of device will be included on the final report.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that patient was not affected and on priming a centrimag pump to initially place a patient on support, centrimag pump would not fit into motor.The clinician stated plastic was too thick on pump head to fit into motor.A new pump head was primed and fit into motor.Patient was on support.The clinician state that they primed a circuit and went to lock the pump head in the motor and it would not lock.It seemed the plastic on the groove was too thick.The pump was replaced and patient doing fine on a different pump at time of reported event.It was noted that the pump will be returned for analysis.Additional information was requested but not provided.

Manufacturer Narrative

Section a1: correction - patient identifier section b5, d4, d11, h8: correction section h4: additional information - device manufacturing date section h6: additional information manufacturer's investigation conclusion: the reported event of the centrimag blood pump not being able to fit in the motor could not be confirmed through this evaluation.A specific cause for the reported event could not be conclusively determined through this evaluation.The centrimag motor instructions for use (ifu) provides instructions for how to mount the blood pump on the motor.This document additionally states to always have a backup centrimag system available for use.Review of the device history record (dhr) for the centrimag motor revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer reference number: 2916596-2019-03444.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8851987
• MDR Text Key: 152976415
• Report Number: 2916596-2019-03446
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 7640135140078
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG BLOOD PUMP (L06310-LA7)
• Patient Age: 25 YR
• Patient Weight: 82