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

Model Number ROTAFLOW

Device Problems Break (1069); Electrical /Electronic Property Problem (1198); Inaccurate Flow Rate (1249); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but has not yet been received.

Event Description

It was reported that during the dearing of the rotaflow the flow value is unstable.Even when the rotaflow is set to 0 rpm the rotaflow drive starts and values between 600-800rpm are displayed.Also when the cart is moved the flow value is unstable.The error message ¿head error¿ was displayed on the rotaflow when the customer removed the rotaflow drive while the device was spinning.The "head error" could not be reproduced by the technician.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow "flow value is unstable" and the error message "head error" has been displayed.A getinge service technician found the rotflow drive (serial#(b)(6); material#(b)(4)) to be faulty.The affected drive was sent back to the supplier emtec on (b)(6) 2021 for further investigation.On (b)(6) 2021 emtec was unable to reproduce the reported failure "head error" and "flow unstable".In addition it was found that the rotaflow closing assy (material#(b)(4)) is broken.The rotaflow closing assy (material#(b)(4)) has been replaced.The rotaflow drive works as intended.Based on these investigation results the reported failure "flow unstable and head error" could not be confirmed by the supplier.However the failure mode "flow unstable" can be linked to the following most possible root causes according to our risk management file (dms# (b)(4)).Malfunction of the flow measurement system: -zero flow calibration failed - incorrect flow measurement the following most possible root cause could be determined for the head error: - 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.-if the rpm / lpm is set to zero and the drive as well as the inserted centrifugal pump is 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.The reported failure "closing assy broken" could be confirmed.An investigation of a rotaflow system that exhibited a similar issue was performed in getinge life cycle engineering on (b)(6) 2016.Most probable root causes could be determined: - too excessive force - weakening due to manufacturing errors (air inclusions) - weakening due to aging.Uv light (sun) or contact with chemicals.The product in question was produced in (b)(6) 2016.The review of the non-conformities has been performed on (b)(6) 2021 for the period of (b)(6) 2016 to (b)(6) 2021.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.In order to avoid reoccurrence of the reported failure, the user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.3| en | v14.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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: 11639960
• MDR Text Key: 244625170
• Report Number: 8010762-2021-00238
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 701035130
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2021
• Patient Sequence Number: 1