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

Model Number CARDIOHELP-I

Device Problem Pumping Stopped (1503)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair.The failure could not be re-plicated and no parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow up will submittend when additional information become available.

Event Description

The customer reported "device stopped pumping after hls accidentally disconnected"the customer had an issue resuming pump after the disconnection and reconnection of the hls.Found to be a user-related error, rather than any functionality issue with the pump itself.Calibrations, functional testing, and safety testing all passed per factory specifications.Device returned to customer.It was reported that the cardiohelp showed the alarm ¿pump disposable error¿.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the device stopped pumping after the hls module was accidentally disconnected.The customer had an issue resuming the pump after the disconnection and reconnection of the hls.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation and repair.The failure could not be replicated and no parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.It was confirmed by the getinge service and sales unit, that incident occurred the night/early morning of (b)(6) 2023.The log files of the reported cardiohelp were reviewed and the error messages "no disposable detected" and "pump disposable error-stop" could be confirmed on (b)(6) 2023.Both error messages are the result of the reported disconnected disposable.It was confirmed by the customer that the root cause could be linked to an user error.In the instruction for use (ifu) of the cardiohelp is stated that it is necessary to decrease the flow to zero before disconnecting and connecting the disposable to the device.The ifu of the cardiohelp includes a warning under chapter 2 "do not remove the disposable product during normal operation." furthermore, in the ifu of the cardiohelp, it is stated in chapter 2.1.4 "please refer to the respective instruction for use of the disposables".In reference of the current ifu for disposables the following is stated in chapter 5.3.1 "safety instructions for the oxygenator", incorrect installation of the hls module advanced can lead to device malfunction.This can endanger the patient.Use the device only together with the device cardiohelp-i.Install or remove the device only when the pump of the cardiohelp-i is at a standstill (0 rpm).Ensure that the device is fitted onto the device correctly and securely fixed, to eliminate the risk of magnetic decoupling between the drive and the centrifugal pump.The device was manufactured on 2022-02-10.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6) was reviewed on 2023-10-20.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the ifu.Based on the results the reported failure "device stopped pumping after hls accidentally disconnected" could be confirmed, but is not a device related malfunction.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.

• 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: 17973911
• MDR Text Key: 326195221
• Report Number: 8010762-2023-00512
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose