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

Model Number CARDIOHELP-I

Device Problems Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up will be submitted when additional information becomes available.

Event Description

It was reported that the cardiohelp is going into emergency mode unprompted.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the cardiohelp is going into emergency mode unprompted.The instance of time is unknown.It was confirmed that no patient was involved.A getinge field service technician (fst) was sent for investigation and repair on 2023-10-17/18 and 2023-10-26.The reported failure could not be replicated and no parts in relation to this failure were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files were analyzed by the fst and it was logged that the emergency mode was engaged by the user.Further, no malfunction could be confirmed on the date of event.According to the risk file v24 of the cardiohelp the following root cause can lead to the reported failure - communication to motion controller disturbed based on the results the reported failure "cardiohelp is going into emergency mode unprompted" could not be confirmed.To avoid re-occurrence 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.

Event Description

Complaint id (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the cardiohelp is going into emergency mode unprompted.It was confirmed that no patient was involved.A getinge field service technician (fst) was sent for investigation and repair.The reported failure could not be replicated and no parts in relation to this failure were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files were analyzed by the fst and it was found that the emergency mode was engaged by user.Further, no malfunction could be confirmed on the date of event.According to the risk file v24 of the cardiohelp the following root cause can also lead to the reported failure: - communication to motion controller disturbed the device was manufactured on 2021-08-30.The device history record (dhr) of the cardiohelp (material: 701072780, serial: 90414609, elo#: 1157363) was reviewed on 2023-08-02.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 is going into emergency mode unprompted" could not be confirmed.To avoid re-occurrence 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: 17359653
• MDR Text Key: 319381917
• Report Number: 8010762-2023-00346
• 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,Followup
• Report Date: 11/14/2023

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: 07/14/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 10/30/2023; 10/30/2023
• Supplement Dates FDA Received: 11/10/2023; 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1