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

Catalog Number 70104.7041

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Death (1802)

Event Date 04/29/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

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).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) 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.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.The device is not available for laboratory investigation.

Event Description

(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
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 8646429
• MDR Text Key: 146249440
• Report Number: 8010762-2019-00148
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: 70104.7041
• Device Lot Number: 70124475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No
• 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