MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 70000

Device Problem Decrease in Pressure (1490)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation yet.The sample is currently blocked in hospital for health ministry inspection.Maquet cardiopulmonary (b)(4) will submit a supplemental medwatch on receipt of further information.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the hospital: during extracorporeal circulation, before cross clamping the aorta, an increase in pressure drop was reported by perfusionist.All pressure transducer where controlled and all worked fine.Extracorporeal circulation was closed in safety, the oxygenator was replaced and then the extracorporeal circulation started again and surgery where performed.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption #(b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The device has not been returned for evaluation yet.The sample is currently blocked in hospital for health ministry inspection.Maquet cardiopulmonary gmbh will submit a supplemental medwatch on receipt of further information.

Event Description

Ref.: #(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7995260
• MDR Text Key: 124967995
• Report Number: 8010762-2018-00285
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Model Number: VKMO 70000
• Device Catalogue Number: 701067942
• Device Lot Number: 92253389
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1