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 04/27/2023

Event Type  malfunction  

Event Description

Information received, that a patient was involved and the cardiohelp was exchanged during treatment.The customer noticed that there was a visual alarm, but no audible alarm.They did not try the emergency drive because the unit was functioning properly, besides the audible alarm.The unit was replaced with a different cardiohelp.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the alarm audio is not working.Initally no patient involvement was reported.On 2023-08-14 the information received, that the cardiohelp was exchanged during treatment.A getinge field service technician (fst) was sent for investigation and repair.The failure could be replicated and the main speaker was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The provided log files does not include the reported date of event: (b)(6) 2023.The event date was confirmed by getinge service and sales unit and no more log files could be provided.Thus a log file analyses could not be performed for the reported event date.According to the risk file v24 of the cardiohelp device (dms# 2021972) the following root causes can lead to the reported failure: existing alarms not recognized caused by technical error for example: insufficient alarm system, loudspeaker failure, sound pollution.Further, in the "instructions for use (ifu, chapter 4.7 "switching on the cardiohelp-i, self test") it is stated that the speaker has to be checked during the self test of the cardiohelp.Thus, a defect speaker will normally be noticed before use.Further the speaker should be checked every day during use (refer ifu, chapter 2.2.6).The device was manufactured on 2022-01-18.The device history record (dhr) of the cardiohelp was reviewed on 2023-05-09.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 "alarm audio is not working" 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: 17660458
• MDR Text Key: 322368755
• Report Number: 8010762-2023-00435
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1