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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the cardiohelp is going into emergency mode unprompted.The getinge field service technician was unable to reproduce the failure and was sending the device in for evaluation.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 field service technician was unable to reproduce the failure and was sending the device to the depot repair center for evaluation.A getinge field service technician (fst) of the depot center investigated the cardiohelp device on 2023-06-27/29.No part was replaced.The cardiohelp was tested for two weeks at 3200 rpm.The fst could not verify that the unit goes into emergency mode unprompted.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.(refer to service order (b)(4)).An exact root cause could not be determined, as the failure is not reproducible.According to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: - communication to motion controller disturbed; - wrong speed; - wrong flow direction (tubes).The device history record (dhr) of the cardiohelp was reviewed on 2023-05-26.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 "going unprompted into emergency mode" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-05-19 till 2023-05-19) 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).

• 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: 16991364
• MDR Text Key: 315830346
• Report Number: 8010762-2023-00238
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1