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

Model Number BEQ-HMOD70000-USA

Device Problem Material Discolored (1170)

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

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

For a patient receiving veno-arterial ecmo, it was noted on the pre membrane side of a quadrox oxygenator that there was a discolouration of the potting on two sides.The photo provided shows that there was a green/yellow discolouration.While it currently does not seem to have had any effect on the patient receiving ecmo therapy, it is unclear why this discolouration has occurred and if it is going to have any clinical significance for the patient.The circuit prior to use was set up and primed on (b)(6) 2016.No interventions were required.Successfully weaned the patient from v-a ecmo on (b)(6) 2016 with no apparent complications as of yet.Will continue to monitor the patient.If this is to occur again we will be sure to save any oxygenator for analysis.(b)(4).

Manufacturer Narrative

The product in question was not available for laboratory investigation.Therefore a production sample of the same kind was used for testing purposes.Hypothesis: the hypothesis of the reported failure is as follows: the tpu fiber of the water side is yellow colored, the gas fiber of the gas side pure white.Due to this a slight difference of color is visible.When the oxygenators water side is filled with water the difference is more obvious.Also a colored disinfection agent for the water of the heater cooler unit could cause a more obvious difference.Test procedure: the product was filled with water.It could be determined by the pictures made that the tpu fibers of the filled product looked more darker / yellowish than during the unfilled condition.Therefore a discoloration / color change of the products tpu fibers during use could be confirmed.Beside of this the water side of the product was also filled with blue colored water and the blue color was visible within the tpu fibers from both sides of the oxygenator.Based on these results the reported failure "discoloration pre membrane side" was most probable caused by a colored substance within the water of the hu 35 used pre or during the treatment.The cause of the failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.The failure was determined to be the first of its kind and is being handled through a designated maquet cardiopulmonary trending process.

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: 5833555
• MDR Text Key: 52120976
• Report Number: 8010762-2016-00491
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701053824
• Device Lot Number: 70109313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Date Device Manufactured: 12/01/2015
• 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