MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

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

Patient Problems Hematoma (1884); Swelling/ Edema (4577)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

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

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) 2023.The information was provided that the patient suffered an edematization of the right lower extremity associated with an intramuscular hematoma." complaint id (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh has received the following information from the spanish agency of medicines and medical device on 2023-05-12: 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 2023-03-29.The information was provided that the patient suffered an edematization of the right lower extremity associated with an intramuscular hematoma.On 20223-06-06 the customer confirmed that neither the cardiohelp, hls set, nor the hls cannulas are involved in the event.Based on the available information the reported event " patient suffered an edematization of the right lower extremity associated with an intramuscular hematoma" could be confirmed, but was not related to a device malfunction.This complaint was found in the database of customer complaints as a single event (timeframe from 2022-03-21 till 2023-03-21).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.H3 other text : hls set was discarded by customer.

Event Description

Complaint id# (b)(4).

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, 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: 16960295
• MDR Text Key: 315530332
• Report Number: 8010762-2023-00219
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000239766
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening