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

Model Number CARDIOHELP.I

Device Problem Noise, Audible (3273)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that the device was making an odd noise.The failure occurred during treatment and the cardiohelp as well as the hls set were replaced during treatment.A getinge field service technician (fst) was sent for investigation.The failure could not replicated and no parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The fst stated that the most probable root cause was coagulation built-up in the hls set which caused the noise.According to the instructions for use (ifu) of the cardiohelp device, chapter ¿general precautionary measures during use¿ it is stated that if the centrifugal pump makes any abnormal noises, the disposable on the cardiohelp-i (e.G., hls set advanced or quadrox-ir) should be changed.The device was manufactured on 2022-04-21.The device history record (dhr) of the cardiohelp was reviewed on 2024-03-15.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 "odd noise coming from the device" could be confirmed, but is not related to a malfunction of the device.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2023-03-12 till 2024-03-12).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 affected hls set will be investigated within complaint# (b)(4) (mfg report number: 8010762-2024-00155).

Event Description

It was reported that user perceived a noise coming from the device.The cardiohelp and the disposable have been exchanged during treatment.No harm to any person has been reported.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: 18976978
• MDR Text Key: 338611851
• Report Number: 8010762-2024-00163
• 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
• Report Date: 03/20/2024

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.I
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1