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

Model Number HLS SET

Device Problem Insufficient Information (3190)

Patient Problem Ischemia Stroke (4418)

Event Date 05/12/2022

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

Following was initially reported: incident description: ¿ischemic stroke¿.Consequences for the patient: patient¿s death.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

This is a follow up report to complaint (b)(4) which was reported under mfr# 8010762-2023-00003 on 2023-01-04.  getinge has been received new information on 2023-02-01 by the ssu (sales and service unit) in regards the involved product therefore, the reporting decision changed from reportable to non reportable.The event reported to the authorities by the customer with aemps reference (b)(6) has no getinge product involved.The product related to the event is centrimag, manufactured by abbott.The complaint information has been submitted to the legal manufacturer abbott.As getinge is not the legal manufacturer of the reported product, this is not considered as a customer product complaint for getinge, therefore no further investigations will be performed.

• Brand Name: HLS SET ADVANCED
• 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: 16093031
• MDR Text Key: 306584613
• Report Number: 8010762-2023-00003
• 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,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death