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

Model Number MCP00703157#RFC 20-970 ROTAFLOW CONSOLE

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/15/2021

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 (b)(6).It was reported that the flow rate dropped on the rotaflow console from 5l/min to 0.5l/min even though they didn't touch the rotary knob.The flow rate dropped, apparently after rotaflow bumped into a hospital staff member while moving through the hospital.After the flow rate dropped, the emergency drive was used to maintain circulation.Shortly after this problem occurred, it was replaced with an ecmo device from a different manufacturer.No harm to the patient has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in japan.It was reported that the flow rate dropped on the rotaflow console from 5l/min to 0.5l/min even though they didn't touch the rotary knob.The flow rate dropped, apparently after rotaflow bumped into a hospital staff member while moving through the hospital.After the flow rate dropped, the emergency drive was used to maintain circulation.Shortly after this problem occurred, it was replaced with an ecmo device from a different manufacturer.No harm to the patient has been reported.The affected rotaflow console (rfc) with s/n 100052 was investigated by a getinge field service technician and the reported failure could not be reproduced.The rfc was tested approximately 10 hours and the flow rate was constant and stable during the test.The device is back in use.Based on the investigation results the reported failure "flow dropped" could not be confirmed.However the failure mode "flow dropped" can be linked to the following most possible root causes according to our risk management file.- zero flow calibration failed.- incorrect flow measurement.- device used out of specification.- malfunction of bubble/flow sensor electronics.- dried contact gel.- user forgot renewing contact gel.- sensor not detected although sensor is connected.- device used out of specification.- software error.The review of the non-conformities was performed on 2021-11-18 and during the period of 2017-09-16to 2021-11-18 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 2017-09-16.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: 12834151
• MDR Text Key: 280927972
• Report Number: 8010762-2021-00613
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703157#RFC 20-970 ROTAFLOW CONSOLE
• Device Catalogue Number: 701028716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose