MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701034371-HCU 30

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Death  

Manufacturer Narrative

Very limited information is currently available as sole source of data is vague letter received from family member of descendent.A follow-up emdr will be submitted when additional information becomes available.

Event Description

Based on the claimed event reported by the patients family we became aware on 2020-01-20 and opened up a complaint.The patients family reported they believe their father contracted a bacterial infection with a source of a maquet product in connection with a surgery in 2014 and subsequent death in 2017.It is unclear whether the information in the report from decedent¿s family are of factual nature.Thus it is not clear if the product in question was the ultimate cause of death or its initial source.Complaint: (b)(4).

Manufacturer Narrative

The managing director of maquet cardiopulmonary forwarded the letter from a relative of the patient to maquet cardiopulmonary gmbh, dcu on (b)(4).All complaints since 2014 were reviewed on 2020-01-21, but no complaint was found that could be related to the reported event.Therefore complaint no (b)(4) was created after consultation with the director of regulatory affairs on 2020-01-23.In order to fulfil possible reporting obligations, this event was reported on: 2020-01-28 initial mir to united kingdom.2020-02-11 initial emdr.2020- 02-12 initial report to row.2020-03-27 follow up 1 mir to united kingdom.On 2020-02-26 mcp sent a letter to the relatives of the patient to inform them about the ongoing complaint investigation.A request for clarification of the complaint report was sent to the customer on 2020-03-10 (reference no foi request (b)(4)).The freedom of information (foi) department from the (b)(6) hospital nhs foundation trust has responded to the foi request (b)(4) on 2020-04-27.During the investigation it was confirmed that the hospital does not use any maquet cardiopulmonary (mcp) devices.Therefore maquet cardiopulmonary gmbh is not the legal manufacturer of the product in question and this is not a customer product complaint by definition (reference to (b)(4) customer product complaint handling process).

Event Description

Complaint: (b)(4).

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9694062
• MDR Text Key: 178579910
• Report Number: 3008355164-2020-00001
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 701034371-HCU 30
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2020
• Distributor Facility Aware Date: 04/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2020
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death