MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR WITH INTEGRATED HEAT EXCHANGER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMOD 70000-USA #SQU

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

Patient Problems Air Embolism (1697); Death (1802)

Event Date 11/26/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Device requested but not yet received.

Event Description

According to the hospital: (b)(6) called and claimed the patient had an air embolism, most likely caused by the central line, but hospital policy required him to call in a complaint.He does not "beleieve" it was the oxygenator.Additional information: patient had an air embolism which lead to her death.The incident occurred during use.Was the oxygenator exchange with a new one? yes.Air was in the system which led to the air embolism? air source was not identified with 100% certainty.Micro air was entrained into the system with subsequent delivery to the patient.The used tubing set was from medtronic.Oxygenator doesn´t have any other abnormalities.Internal reference: (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).Maquet gmbh requested the product for investigation in the laboratory of the manufacturer.The returned oxygenator was investigated in the laboratory of the manufacturer.A quadrox-id adult without tubing was returned.The sample was contaminated.The venting membrane was bloody and was sent back without screw cap.Oxygenator was cleaned with sodium hypochlorite.Leak test according lv 201 was performed.A leak at the venting membrane was detected and documented.The deaeration membrane was closed and a leak test was carried out again.No further leaks could be detected.Since the oxygenator was returned without tubing, the readjustment test could not be performed and the cause of the failure cannot be determined.Thus the reported failure "air in the system" could not be confirmed.According to the territory manager from 2019-02-12 "the yellow cap of the venting membrane was attached to the venting connector at the time of the event", therefore the detected leakage which was found in the laboratory during investigation could not lead to the reported failure and additionally no evidence was provided that this failure was noticed within the initial complaint report.Clinical assessment created by our therapy application manager on 2019-02-13: "there is currently no evidence that the quadrox used contributed to air penetration into the ecc system.It is assumed that the intended use of the claimed oxygenator at the time of the event was not restricted.The device was used in conjunction with a medtronic tube set.According to the opinion of the territory manager, the patient died from air in the system, which probably entered the extracorporeal circulation through the central venous catheter (cvc).According to the customer, the opinion is that the oxygenator did not trigger air embolization.These two representations support the rating given above." based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.Since no device related malfunction could be confirmed and no systemic issue could be determined no corrective action is needed at this time.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Internal reference: (b)(4).

• Brand Name: OXYGENATOR WITH INTEGRATED HEAT EXCHANGER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8150941
• MDR Text Key: 129928361
• Report Number: 8010762-2018-00326
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/30/2018,02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2020
• Device Model Number: HMOD 70000-USA #SQU
• Device Catalogue Number: 701067840
• Device Lot Number: 70124628
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2018
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death