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

Model Number CARDIOHELP-I

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2024

Event Type  Death  

Event Description

The event occurred in usa during treatment.No malfunction of the cardiohelp was reported.The customer provides only the information, that there was an incident involving a patient.The incident was not more specified by customer.A getinge technician reviewed service and user pools and did not fnd any high priority alarms.The cardiohelp passed all test during a preventive maintenance as per factory specifications.Complaint id: (b)(4).

Manufacturer Narrative

A follow up will submitted when addtional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The customer confirmed that the patient is no longer alive, therefore this correction is sent.A getinge field service technician (fst) was sent for investigation.No malfunction could be confirmed and no parts were relaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The device was manufactured on 2014-09-08.The review of the non-conformities has been performed on 2024-04-11 for the period of 2014-09-08 to 2024-04-04.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.A follow up will submitted when additional information become available.

• 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: 19078004
• MDR Text Key: 339782127
• Report Number: 8010762-2024-00196
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other