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

Model Number BEQ-HMOD30000-USA

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

Patient Problem Thrombus (2101)

Event Date 02/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested for return but has not yet been received the investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

(b)(4).According to the customer: "this patient continued on ecmo (extra corporal life support) of 100 ml/kg/min.On (b)(6) 2016 08:00 a small clot was on post oxygenator and began increasing in size throughout the day; very small pinpoint clot noted pre oxygenator.On (b)(6) 2016 at 0400 anti xa " the product was exchanged.No patient consequences were reported.No propofol or lipid based drugs were applied.No pressure rise was observed.(b)(4).

Manufacturer Narrative

The product was disposed by the hospital; therefore no manufacturer laboratory investigation was possible.Clotting is a known phenomenon and has been investigated in a previous complaint.The cause of this failure was determined to not be attributed to a device related malfunction.Based on the results of the previous complaint investigation and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.Dhr review: even after repeated inquiries, the information of lot number and serial number is not available, and therefore the requested dhr-review will not be carried out.The complaint sample as well as the information about the lot number and the serial number was not transmitted to mcp, and this will also not occur in the future.Based on this a confirmation of the failure is not possible.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5486258
• MDR Text Key: 40207415
• Report Number: 8010762-2016-00156
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 70105.0330
• Device Lot Number: 70102416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1