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

Model Number 102953

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.

Event Description

Related manufacturer reference number: 2916596-2019-03446.

Manufacturer Narrative

Section a1: correction: patient identifier.Section b5 and d11: correction.Section d10, h3, h4: additional information.Section h5: correction.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 based on the evaluation of the returned blood pump.It was reported that upon priming the centrimag blood pump on (b)(6) 2019 to initially place the patient on support, the blood pump would not fit into the motor and it would not lock in place.The clinician reportedly stated that it was felt that the plastic was too thick on the groove of the pump head to fit into the motor.The blood pump was required to be forcefully pushed, generating damage to the outside of the pump.A replacement blood pump was primed and reportedly fit into the motor without issue.The patient was not adversely affected due to the event.A video clip was submitted, which showed the user mounting the centrimag blood pump, lot number: l06310-la7, on a demo centrimag motor per the reported information.The video clip appeared to show that the blood pump was able to be properly mounted on the motor; however, the amount of torque required by the user to mount the pump on the motor in the correct orientation could not be determined based on the video.The centrimag blood pump, lot number: l06310-la7, was returned for evaluation.Visual inspection of the returned blood pump revealed no evidence of atypical depositions.There was no evidence of separation or slippage between the rotor magnet and rotor body.Examination of the pump ports, rotor, and rotor well revealed no evidence of damage.However, visual and microscopic inspection of the blood pump revealed areas of damage on the circumference of the pump housing near the locking grooves.The damage on the circumference of the pump housing appeared consistent with abrasion and is consistent with the report that the center forcefully pushed the pump into the motor, generating damage to the outside of the pump.The blood pump was forwarded to abbott manufacturing personnel in zurich, switzerland for additional analysis.The blood pump was able to be successfully mounted onto multiple test motors when an adequate mounting torque was applied.Of note, the motor in use at the time of the reported event, serial number: (b)(6), was not returned for evaluation.A specific cause for the reported event could not be conclusively determined through this evaluation.A device history record (dhr) review did not identify any product manufacturing related issues or non-conformances.Although the investigation did not confirm the reported event and determined that the blood pump met the current established specifications, a capa was initiated to further investigate the current inspection process/specifications.The centrimag blood pump 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• 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: 8851937
• MDR Text Key: 152975824
• Report Number: 2916596-2019-03444
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• 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 Expiration Date: 12/31/2021
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L06310-LA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• 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 MOTOR (L01782-0011).
• Patient Age: 25 YR
• Patient Weight: 82