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

Model Number MCP00706037#ROTAFLOW ENGLISH EU-PLUG

Device Problem Pumping Stopped (1503)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred in south korea.It was reported that the rotaflow console has an unexpected ¿pump stop¿ without any action by a user during patient use.The pump has been stopped and the device works normally after turning on.No alarms occurred or messages displayed.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in south korea.It was reported that the rotaflow console has an unexpected ¿pump stop¿ without any action by a user during patient use.The pump has been stopped and the device works normally after turning on.No alarms occurred or messages displayed.No harm to any person has been reported.A getinge field service technician investigated the affected rotaflow console (rfc) with s/n (b)(6) and during the investigation the reported failure "unexpected pump stop" could not be reproduced.The rfc was tested and neither abnormalities nor any evidence of any failure or incorrect function were found.As a precaution the potentiometer (article number (b)(4)) has been replaced.The device was working as intended and is back in use.A possible cause for the reported failure error could be a cable break/ faulty solder joint of the cable from the flow potentiometer to the control board or a defect in the potentiometer itself.If the user disconnect the reference voltage of the second track of the potentiometer during operation, the reported failure could occur.The console stops the drive regardless of the potentiometer position and without an error message.For the control system, it looks like as if the potentiometer is set at "0", while the safety system sees a higher set speed.The rotaflow only monitors when the speed is too high.If the speed is too low, no error will be displayed.If the other track is manipulated, error run-away or error-head is displayed.An error at the reference voltage is rather unlikely.It is monitored and a deviation is indicated with error reference.Based on these investigation results the reported failure "unexpected pump stop" could not be confirmed.However, the failure mode "unexpected pump stop" can be linked to the following most possible root causes according to our risk management file (dms# 2023689): software error wrong intervention limits; unintended rpm change by user; unintended switch off by user.The review of the non-conformities was performed on 2023-02-20 and during the period of 2012-07-01 to 2022-02-20 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console in question was produced in 2012-07-01.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.Chapter 2.2.4 general precautionary measures during use if the pump stops during an application, the blood flow will be interrupted and supply to the patient will cease.Eliminate the cause of the pump stop and start the pump again as soon as possible.2.2 general safety instructions there is the risk that acoustic alarms emitted by the rotaflow system may not be heard.You should therefore position the system so that you can see the displays on the rotaflow console and any optical warning signals at all times.3.3.4 battery operation "status of the power supply during battery operation" the acoustic alarm can be switched off with the "audio off" button.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16402050
• MDR Text Key: 310097611
• Report Number: 8010762-2023-00093
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706037#ROTAFLOW ENGLISH EU-PLUG
• Device Catalogue Number: 701043290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1