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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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).
 
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Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
Type of DeviceOXYGENATOR, 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 Key7436123
MDR Text Key105898008
Report Number8010762-2018-00137
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD70000-USA#Q
Device Catalogue Number701053824
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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