MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP

Device Problem Communication or Transmission Problem (2896)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information become available.A getinge field service technician was sent for investigation on (b)(6) 2021.He could confirm the reported failure and replaced the flow/bubble sensor.The unit was tested and put back in use.Root cause analysis is still ongoing.

Event Description

Customer reported the flow bubble sensor was alarming "arterial air" and unit shut down.No indication of actual or potential for harm or death was reported.Complaint number: (b)(4).

Manufacturer Narrative

A getinge field service technician was sent for investigation on 2021-11-24.He could confirm the failure and replaced the flow/bubble sensor.The technician performed safety, calibration, and functionality checks to factory specifications.All tests passed.The log files were analyzed by getinge and shows no malfunction of the cardiohelp.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6), elo#: 1117761/v1) was reviewed on (b)(6) 2022.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

Customer reported the flow/bubbles sensor was alarming "arterial air" and unit shut down during treatment.The log files were analyzed by getinge and shows no malfunction of the cardiohelp.The affected flow/bubble sensor was investigated by getinge life-cycle-engineering on 2022-06-10.Within the investigation no malfunction of the flow/bubble sensor could be confirmed.Based on the evaluated facts above, the reported failure "flow/bubble sensor alarming arterial air" could not be confirmed.However the failure mode can be linked to the following most possible root causes according to our risk management file (dms#(b)(4)).- influence due to other ultrasonic devices (e.G.Flow sensor).- bubble sensor not plugged but recognized.- connection of non-compatible sensor.- environmental influences (atmospheric pressure, temperature, humidity, emi, over voltage).- sensors are disturbed by external electric or magnetic field (emi) or ultrasonic system.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6), elo#: (b)(4)) was reviewed on 2022-01-26.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.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

Complaintnumber: (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: 12766793
• MDR Text Key: 280452347
• Report Number: 8010762-2021-00587
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 03/08/2022; 06/14/2022
• Supplement Dates FDA Received: 03/23/2022; 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1