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 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information become available a getinge service technician will investigate the device in question.

Event Description

A "drive 1 fan defective" error message during treatment was reported.No indication of actual or potential for harm or death.Complaint number:(b)(4).

Manufacturer Narrative

It was reported that the error message "drive 1 fan defective" was displayed on the cardiohelp during treatment.A getinge field service technician was sent for investigation on 2021-09-07.He could confirm the failure and replaced the drive fan to restore function.The unit was tested and put back in use.This type of malfunction was already investigated by getinge life cycle engineering within another complaint.The most probable root cause could be determined as a defective output of the power switches v73 and v76.This can be causes by electrostatic discharge.Based on the results the reported failure "drive 1 fan defective" could be confirmed.For the safety of the patient the cardihelp 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.It can be confirmed that the mitigation of the cardiohelp have worked according to factory specifications.The instruction for use (ifu, chapter: 2.2.1 general risks in the use of heart-lung support systems) includes the warning: "check that the ventilation openings are not covered, reduce the ambient temperature and, where medically acceptable, reduce the flow rate.If a fan is defective, use a replacement device and have the fans replaced by authorized service personnel." 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.

Event Description

Complaint number: (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
• MDR Report Key: 12363940
• MDR Text Key: 268026123
• Report Number: 8010762-2021-00472
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• 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
• Date Manufacturer Received: 09/09/2021
• Patient Sequence Number: 1