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

Model Number BEQ-HMOD70000-USA#Q

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was not any longer available for investigation.The oxygenator was scrapped by the customer.A review of similar complaints was performed and the incident was investigated within a previous complaint ((b)(4)) with the following outcome: based on the reported event and our investigation, the event was caused by use that is beyond the use described in our labeling and approved intended use.The instructions for use g-152 (art.# 70105.1053 v04, common device name: ifu-usca: quadrox-id adult g-152) clearly state the following: chapter 4: warnings and precautions, page 7: when using the oxygenator, methylene blue must not be administered directly before or during perfusion.Use of methylene blue may affect the permeability of the membrane and result in consequences for the patient.Based on this and the information available at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.The oxygenator in question operated within maquet cardiopulmonary specifications.The reported incident was most probable caused by off label use.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

According to the customer: after the patient was taken off cardiopulmonary support, the team was cleaning the cardioquip heater cooler and noticed a blue tint to in the water.The patient had been on methylene blue to treat vasoplegia.They think that the methylene blue leached from the blood into the water across the plastic heat exchanger.The methylene blue was given during hls support and was used to treat vascular resistance.(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: 7436123
• MDR Text Key: 105898008
• Report Number: 8010762-2018-00137
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD70000-USA#Q
• Device Catalogue Number: 701053824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• 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