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

Model Number BEQ-HMOD70000-USA#Q

Device Problem Defective Device (2588)

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

Event Date 04/08/2019

Event Type  malfunction  

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

It was stated that the oxygenator was exchanged during treatment due to poor performance and patient po2 levels dropping.No harm to the patient was reported.(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 investigation has been performed by getinge laboratory.During visual inspection several small clots were detected on both sides.Thus the failure could be confirmed.Device history record was reviewed.There were no references found which are indicating a non-conformance of the product in question.The most probable root cause what exactly caused the clots in the oxygenator could not be determined in the laboratory.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Internal reference: (b)(4).

• Brand Name: OXYGENATOR WITH INTEGRATED HEAT EXCHANGER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8541001
• MDR Text Key: 143034250
• Report Number: 8010762-2019-00106
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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: 03/26/2020
• Device Model Number: BEQ-HMOD70000-USA#Q
• Device Catalogue Number: 701053824
• Device Lot Number: 70123412
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention