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

Model Number CARDIOHELP-I

Device Problem Insufficient Information (3190)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/27/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

The vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through renacer registry about an incident involving the product ¿cardiohelp system¿, manufactured by getinge and distributed by, occurred on (b)(6) 2022, in the hospital (b)(6).The reference number assigned to this incident is (b)(4).The information provided is the following: incident description: subarachnoid hemorrhage.Consequences for the patient: required medical to prevent permanent impairment or damage.Other comments: withdrawal of the antithrombotic treatment.Patient¿s current status: the patient died.Complaint id (b)(4).

Event Description

Complaint id (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh was received the following information from the spanish agency of medicines and medical devices on 2023-09-08: the vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through renacer registry about an incident involving the product ¿cardiohelp system¿, manufactured by getinge and distributed by, occurred on 2022-09-27.The information was provided that the patient had the incident "subarachnoid hemorrhage" and the consequence for the patient was "required medical action to prevent permanent impairment or damage".The patient expired.The getinge service and sales unit (ssu) could not get any further information from the customer as the event date was in the very past.Upon investigation of the getinge ssu the complaints which are related to the renacer program generates many incident notices that most of the time are not related to the device.Based on the available information the reported event "subarachnoid hemorrhage" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-09-08 and 2023-09-08).The customer will be informed about the results by the getinge sales and service unit.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: 17719245
• MDR Text Key: 323061735
• Report Number: 3008355164-2023-00039
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2023
• Distributor Facility Aware Date: 12/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2023
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death