MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number ROTAFLOW DRIVE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

The rotaflow displayed the error message "head error" during priming of the system.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was "head error".According to service order (b)(4) dated on (b)(6) 2020 a getinge service technician could not duplicate the error message "head error".The device in question has been subjected to an intensive functional test.The error message is related to the rotaflow drive.The connections cable of the rotaflow drive has been moved in all directions.The "head error" could not be reproduced this way.The device works faultlessly.2020-07-01:the concerned drive was received for further investigations by maquet under rma#41099.2020-07-07:the failure "head error" could not be confirmed in the service department.2020-07-31:drive was send to the supplier em-tec for further investigation.2020-08-27: the failure "head error" could not be confirmed by the supplier em-tec.According to service order rma2002-10245 dated on 2020-08-27 the rotaflow drive was investigated and following diagnosis was provided: the head error could not be confirmed.Drive shows unusual vibrations.A detached ring on the magnet coupling leads to the unusual vibrations.The magnetic coupling has been replaced.The final test for the product status report has been passed.Most possible root cause could be determined as: unknown.In addition the following most possible root cause could be determined for the head error: 1.The head error follows the sig error.When the ultrasonic cream is applied (due to the sig error) to the flow bubble sensor and the disposable is moved close to the rota flow drive, the magnets in the centrifugal pump interfere with the sensors in the rota flow drive.This error can be overwritten by restarting the rota flow console.2.If the rpm / lpm is set to zero and the drive as well as the inserted centrifugal pump are shaken this causes magnetic uncoupling of the centrifugal pump and thus leads to the head error.This error can be overwritten by restarting the rota flow console.Furthermore, the instructions for use of the rotaflow system, see rotaflow instruction for use, instructions for use | 4.2 | en | 13 contain detailed descriptions to prevent an ¿error head¿.The reported failure" head error" was discovered during priming of the rotaflow.The device was directly involved in the event.The failure could not be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10022569
• MDR Text Key: 189903015
• Report Number: 8010762-2020-00149
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1