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

Model Number 102953

Device Problem Connection Problem (2900)

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

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

The medsun report is (b)(4) the patient weight was not provided.The event date is estimated.The serial number of the device was requested but was not provided, therefore the age of device is unknown.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

Information was received on 06jun2018 from a medsun report form stating: "patient was on venous-venous ecmo using centrimag with oxygenator, the centrimag began alarming pump failure so two rn's emergently switched the device over to the back-up controller.No harm to the patient, but high potential for harm.".

Manufacturer Narrative

Manufacturing evaluation conclusion: the reported event could not be confirmed and a root cause could not conclusively be determined through this evaluation.No further information was provided.The manufacturer is closing its file on this event.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturing evaluation conclusion: the motor was returned for analysis and the report of a pump not inserted (m3) alarm was unable to be reproduced during the investigation.Full functional testing of the returned motor was performed using laboratory equipment.The motor operated as expected during the testing and at no time did a pump not inserted (m3) alarm occur.The returned motor functioned as intended during analysis.A cause of the ¿motor stopped¿ alarm was unable to be determined.The unit was serviced and returned to the customer.A ¿pump not inserted¿ alarm message is a visual alert which indicates that the system will not start and is accompanied by an audible alarm.The alarms should be silenced by the mute button.If the alarm recurs after the mute button is pressed, the operator(s) should then re-insert the pump and secure it with the locking screw.A review of the device history record revealed no deviations from manufacturing or quality assurance specifications.No further information is available.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 CH-80 05; SZ CH-8005
• MDR Report Key: 7661678
• MDR Text Key: 113190122
• Report Number: 2916596-2018-02727
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR