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

Model Number CARDIOHELP-I

Device Problem Overheating of Device (1437)

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

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up will be submitted, when additional information become available.The investigation is ongoing.

Event Description

It was reported, that the error message "housing fan 1 and 2 defective" occurred.The instant of time was not provided.No harm to any person has been reported.Complaint number: (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

It was reported that the cardiohelp displayed the error message: "housing fan 1 and 2 defective".The failure did not occur during treatment.A getinge service technician (fst) was sent for investigation and repair on 2022-07-28.No parts were replaced.Tightening of a fan cable solved the problem.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The root cause could be confirmed as a streaking fan cable by getinge technician.Furthermore, 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.Morover, 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 review of the non-conformities has been performed on 2022-08-01 for the period of 2010-10-01 to 2022-07-27.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "housing fan 1 and 2 defective" 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: 15154610
• MDR Text Key: 304923974
• Report Number: 8010762-2022-00298
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1