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

Model Number CARDIOHELP-I

Device Problems Overheating of Device (1437); Ejection Problem (4009)

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

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

It was reported that the cardiohelp did not pass the preventive maintenance upper and lower fans are out of specs.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 cardiohelp did not pass the preventive maintenance as the upper and lower fans of the cooling element are out of specification.The failure occurred during repair.A getinge field service technician (fst) was sent for investigation and repair on 2023-05-16.The failure could be replicated and the fans were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files were not provided, but it was confirmed by the fst, that no error message was displayed on the cardiohelp.Further, it was confirmed by fst, that there were no signs of mechanical failure nor excessive dust in the fans.Another fan with a similar failure was already investigated by life-cycle-engineering within another complaint.The fan was confirmed as defective, most likely due to statistical reasons.The system has redundant fans to ensure a proper cooling even if one fan malfunctions.In case of a defective fan a visual and acoustic alarm is generated.In addition an alarm is generated if the internal temperature is too high.According to the service manual (chapter 1.11 service activities) the fans have to be exchanged every 24 months during the maintenance.Furthermore in the instruction for use (chapter 2.2.1 general risks in the use of heart-lung support systems) it is stated that the ventilation openings have to be checked before every use that they are not covered.A cardiohelp with a defective fan should be replaced as quickly as possible.The device was manufactured on 2022-02-16.The device history record (dhr) of the cardiohelp (material: 701072780 serial: (b)(6)) was reviewed on 2023-03-20.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 "cardiohelp did not pass the pm upper and lower cooling fans are out of specs" could 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.

• 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: 16545584
• MDR Text Key: 311413773
• Report Number: 8010762-2023-00138
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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: 701072780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1