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

Model Number CARDIOHELP-I

Device Problems Failure to Read Input Signal (1581); Pressure Problem (3012)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

It was reported that the flow measurement sporadically stops and the pressure is no longer displayed.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the flow measurement sporadically stopped and the pressure was no longer displayed during treatment.The reported failure "flow measurement sporadically stop is investigated in complaint# (b)(4) (mfg report 8010762-2023-00633).A getinge field service technician (fst) was sent for investigation.No part was replaced as the pressure reading failure could not be reproduced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.As the fst could not reproduce the pressure failure, no exact root cause could be identified.However, according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: - wrong plugged external pressure sensor or disconnection (mix up), - disturbed (emi) pressure sensor, - connection of non-compatible sensor, - response time is too long, - positive or negative pressure beyond specification (release of tubes), - too high / low atmospheric pressure.According to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.4, chapter 6.1 preparation and installation and quadrox-ir small adult / adult, chapter 7.2 priming the system) the pressure sensors have to be calibrated and checked before priming.Furthermore, the cardiohelp has a flow/bubble sensor and a venous probe to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.Referring to the instruction for use (ifu) of the cardiohelp, chapter 5.3 "connection the sensors", it is stated to ensure that the connected sensors are not defective and to not use, if there is a visible damage.Moreoever, it is stated in the instructions for use (ifu) of the cardiohelp (chapter 10 "cleaning and disinfection") that the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore in the ifu chapter 5.3 "connecting the sensors" it is stated that the sensors must be kept clean.The device was manufactured on 2021-12-13.The device history record (dhr) of the cardiohelp (material: 701048012, serial: (b)(6)) was reviewed on 2024-01-25.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "pressure is no longer displayed" could not be confirmed.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.Note: the flow failure was already investigated and reported within the complaint# (b)(4).

Event Description

Complaint id: (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: 18333752
• MDR Text Key: 330549186
• Report Number: 8010762-2023-00623
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1