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

Model Number ROTAFLOW DRIVE UNIT, BLUE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from (b)(6) that the rotaflow drive has an head error when the drive is turned on.When the error occurred is unknown till now.Requested but still pending.Complaint id: (b)(4).

Manufacturer Narrative

The affected rotaflow drive has been send to the manufacturer emtec for repair under rma#41222.2020-07-10: the concerned drive was received by maquet.2020-07-16: the failure head error could be confirmed after testing in the service department.Same failure was already investigated at emtec report no.Rma2020-10009 on 2020-02-24 (complaint (b)(4); rma#39725): the defective drive was sent to the supplier em tec for further root cause investigation: 2020-02-24: em tec report no.Rma2020-10009: the reported head error is a result of wrong handling of the user see below causes.The reported failure could be reproduced and confirmed.Most possible root cause could be determined as: 1.The head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.2.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.3.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.4.Connection issues between the rota flow console and the drive can lead to a head error, for example defective pins.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manuel, mcv-ga-10000703-de-11, chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.The reported failure "head error" could 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.

Event Description

Complaint id:(b)(4).

• 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: 10100388
• MDR Text Key: 193675536
• Report Number: 8010762-2020-00183
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 07/27/2020
• Patient Sequence Number: 1