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

Model Number CARDIOHELP-I

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

Event Type  Injury  

Event Description

Maquet cardiopulmonary gmbh has received the following information from the spanish agency of medicines and medical device on (b)(6) 2023: 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.It was reported that there was a oral/dental hemorrhage (major bleeding).Complaint id (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Maquet cardiopulmonary gmbh has received the following information from the spanish agency of medicines and medical device on 2023-03-01: 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.It was reported that there was a orl/dental hemorrage (major bleeding).Further information regarding the event and the involved product has been requested by getinge sales and service unit (ssu) however, no further information was provided by the customer after several attempts.Based on the results the reported failure "major bleeding dental" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe for review between 2022-03-01 and 2023-03-01).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.H3 other text : no further information from customer.

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: 16494878
• MDR Text Key: 310783540
• Report Number: 3008355164-2023-00009
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• 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: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2023
• Distributor Facility Aware Date: 06/29/2023
• Date Report to Manufacturer: 07/20/2023
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening