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).
|
|
Search Alerts/Recalls
|