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

Model Number MCP00706047#ROTAFLOW ITALIAN EU-PLUG

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

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

Event Date 02/29/2024

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 italy.It was reported that the ¿temp error¿ message occurred on the rotaflow console during use.Furthermore, it was stated that the closing assy was also broken.The device has been replaced with another one without consequences for the patient.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in italy.It was reported that the ¿temp error¿ message occurred on the rotaflow console during use.Furthermore, it was stated that the closing assy was also broken.The device has been replaced with another one without consequences for the patient.No harm to any person has been reported.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the reported failures could be confirmed.The rfc power supply board (article number (b)(4)) and the rf drive closing cover kit (article number 701011680) has been replaced.After the replacement the device is working as intended.This closing assy is the first installed to this device in 2014 and age related aspects could be considered.The affected rfc power supply board kit (psb) (article number 701011675) was requested by the getinge field service technician for further investigation but the board is not available.This psb is the first installed to this device in 2014, age related aspects could be considered.Based on the investigation results the reported failures "temp error and closing assy broken" could be confirmed.The failure mode "temp error" can be linked to the following most possible root causes according to the rotaflow risk management file.Overtemperature condition in the device, e.G.: increased heat generation due to short circuits, heat accumulation.The reported failure "closing assy broken" was caused most probably by too excessive force, weakening due to aging (uv light (sun) or contact with chemicals).The review of the non-conformities was performed on 2024-03-12 and during the period of 2014-06-16 to 2024-02-29 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 affected rotaflow console in question was produced in 2014-06-16.In order to avoid reoccurrence of the reported failure "temp error", 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 2.2.2 position of use and operation, and positioning 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.The customer will be informed about the results by the getinge sales and service unit.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 18892763
• MDR Text Key: 337521779
• Report Number: 8010762-2024-00137
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706047#ROTAFLOW ITALIAN EU-PLUG
• Device Catalogue Number: 701043296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention