MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 701047041

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Death (1802)

Event Date 04/29/2019

Event Type  Death  

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the product for investigation but the product was not available.Therefore no laboratory investigation could be performed.A review for similar complaints to be investigated already was performed and no similar complaints were found.During review of the device history records no references were found, which are indicating a non-conformance.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.

Event Description

They reported a pre-membrane pressure of 380mmhg, it was tried to increase the flow and it did not respond, the blood flow to the patient did not exceed 200ml / min.Performed volume test but the patient did not respond.It was not elucidated if the death is exclusively related to disposable.Further information was requested but not received yet.Internal ref.#: (b)(4).

• Brand Name: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9694971
• MDR Text Key: 178608552
• Report Number: 3008355164-2020-00004
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: 701047041
• Device Lot Number: 70124475
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2020
• Distributor Facility Aware Date: 02/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention