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

Model Number HEART-LUNG MACHINE HL 20

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

Patient Problem Death (1802)

Event Date 08/09/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Letter from berufsgenossenschaft rci (translation): the patient, who was insured at the bg rci against work/road accidents, was admitted to the (b)(6) hospital in (b)(6) on (b)(6) 2016 after an accident at work.In the context of intensive medical treatment, the use of an emco system was required.During the treatment the emco malfunctioned and the insured person died.The bg rci is currently checking if damages claims are asserted against third parties.In the above case, it cannot be excluded that the patient died as a result of incorrect treatment or malfunction of the emco system.An expert report is currently being prepared to clarify the cause of death.According to the statement of the (b)(6) hospital (b)(6), the heart-lung machine is a device of your company.Damage claims acc.To paragraph 116 sgs x are to be in our responsibility in case we have to provide any payment according to the law from our side therefore, as a precaution measure and in order to keep the timeline, we are notifying you in regard to any claims according to paragraph 116 sgb x.We kindly ask you to submit us the insurance data for the patient as well as the insurance certificate no.After that we will contact the insurance company in order to discuss the measures of a limitation period.Please contact us in case of further clarification.The bg rci is currently checking the claims for damages due to death of the patient.Also checking, whether there is a malfunction of the ecmo system or it was a medical treatment error.The above process is checking exactly this point as far as we know.In order to be able to claim during the time limit, we kindly ask you (as it is not possible to provide the case data currently) to inform us against whom the investigation in regard of the homicide offence should be stated.Complaint id: (b)(4).

Manufacturer Narrative

The hospital stated the heart-lung machine is from maquet.The quality manager qrc forwarded the letter from bg rci to maquet cardiopulmonary dcu on 2019-12-04.All complaints in sap in 2016 have been reviewed on 2019-12-06, but no complaint was found that could be related to the reported event.Therefore, complaint no (b)(4) was created after consultation with director regulatory affairs on 2019-12-19.In order to fulfill possible reporting obligations, this event was reported on: (b)(6) 2019 to row.2019-12-20 emdr to usa.2019-12-20 initial mir to germany.2020-02-13 follow up 1 mir to germany.The inventory (see below) of the bundeswehr zentralkrankenhaus koblenz was reviewed by quality manager qrc on 2020-03-04.The hospital does not have any hear lung machine.In addition to that no repairs or incidents were reported in regards to the other machines owned by the hospital.Therefore maquet cardiopulmonary gmbh is not the legal manufacturer of the product the hospital complained.This was also stated in the letter of (b)(6) on behalf of maquet cardiopulmonary gmbh, to bg rci on 2020-02-13.Inventory bundeswehr zentralkrankenhaus koblenz: product, material, serial number, note: rfc 20-970 rotaflow console, 701010874, (b)(6), maintenance yes 2020 / complaints no; cardiohelp base unit, 701047999, (b)(6), maintenance until 2018 / complaints no; 70104.8012#cardiohelp-i, 701048012, (b)(6), maintenance yes 2020 / complaints no; cardiohelp-i, 701048012 , (b)(6), maintenance until 2018 / complaints no; cardiohelp-i, 701048012, (b)(6), maintenance yes 2020 / complaints no.

Event Description

Internal ref.#(b)(4).

• Brand Name: HEART-LUNG BYPASS SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9502637
• MDR Text Key: 172204838
• Report Number: 8010762-2019-00397
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEART-LUNG MACHINE HL 20
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death