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

Model Number MCP00703169#RFC 20-970 ROTAFLOW CONSOLE

Device Problem Pumping Stopped (1503)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

The event occurred in italy.It was reported that the rotaflow console stopped during use.No more information provided.More information requested but still pending.No harm to any person has been reported.Complaint id: (b)(4).

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

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in italy.It was reported that the rotaflow console stopped during use.In addition it was reported that the problem occurred when the rotaflow was placed directly into the bed of the patient.Therefore the rotaflow may have been an overheating problem caused by the cooling system being obstructed by the blankets.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 "pump stop" could not be reproduced.The rfc was tested and neither abnormalities nor any evidence of any failure or incorrect function were found.The device is back in use.The most probable root cause could be determined by the getinge technician as overheating due to obstructed the ventilation of the rotaflow console.Based on the investigation results the reported failure "pump stop" could not be confirmed.The review of the non-conformities was performed on 2023-02-23 and during the period of 2014-06-29 to 2023-02-23 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 2014-06-29.In order to avoid re-occurrence 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 general safety instructions make sure that the ventilation openings are not obstructed and the rotaflow system is not covered.There is a risk that the rotaflow system will overheat.Ensure a minimum distance of 50 cm to other devices, objects, or the wall.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.Chapter 2.2.2 position of use and operation, and positioning the rotaflow system must be positioned so that the following requirements are met: the user can see all of the displays at all times.The user can operate all of the controls and components at all times.The user can access all of the interfaces at all times.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: 16441822
• MDR Text Key: 310235264
• Report Number: 8010762-2023-00101
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703169#RFC 20-970 ROTAFLOW CONSOLE
• Device Catalogue Number: 701028712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1