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

Model Number 701043290 - ROTAFLOW ENGLISH EU-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from (b)(6) that a rotaflow console set was installed in last month.The user turned on the unit as a test, and found an error message "head".Engineer checked the unit out and verified that it's caused by a faulty control board.Also cross-checked by connecting the defective board to another unit.According to the user said, she has just turn on/off the unit and never used to a patient yet.The unit has not had any damage or misuse.Complaint id: (b)(4).

Manufacturer Narrative

The user turned on the unit as a test and the head error occurred.The unit was never used on a patient.According to the service order from the getinge field service technician dated on 2020-03-23 the rotaflow control board (701034051) was replaced.Moved the affected rotaflow console & drive unit into a warehouse for investigation.- checked this rotaflow drive unit out by connecting to another rfc(reference unit) and resulted in normal function.Not caused by a defective rfd - these rotaflow console and rotaflow drive could pass functional tests since exchanging the control board with another one.As stated by the field service technician on 2020-03-26 "in accordance with the user, she has never plugged in or out the power line in operation which lead a hot plug.Also the engineer found that the control board was only defective and others could be good condition.It's solved by exchanging this control board.".Most possible root cause could be determined as: 1.The head error is caused by the hot plug.When device is in operation and the power plug is plugged in or out.And this leads to a damage at the control board of the rotaflow.2.The head error follows by the sig error.This is when the ultrasonic crème is applied to the flow bubble sensor.Then the centrifugal pump is causing backflow and this leads to the head error.3.The head error is also caused by shaking the drive.This is when the motor (which is controlled by the optical tacho) is not blocked when adjusting to 0 then it could lead to error when slight shaking.The motor could then slightly rotate.4.The head error can be caused by connection issues between the console (rfc) and the drive (rfd).This is when the cable connection is disturbed by defective pins.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manuel, mcv-ga-10000703-de-11 contain detailed descriptions to prevent an ¿error head¿.The reported failure "head error" occured during testing the unit and could be confirmed.The device was directly involved in the incident.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: 9868370
• MDR Text Key: 200423450
• Report Number: 8010762-2020-00114
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 701043290 - ROTAFLOW ENGLISH EU-PLUG
• Device Catalogue Number: 701043290
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2020
• Patient Sequence Number: 1