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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
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product was not requested to return for manufacturer laboratory investigation as the incident was investigated within a previous complaint 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, 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. For the current record the ifu was reviewed as follows: ifu 1. 0 g-122 03: when using the oxygenator, methylene blue must not be administered directly before or during perfusion. 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 sales person: the customer found the water in the heater cooler unit to be blue, i told them that our heat exchanger is not meant to be used with methylen blue. (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 Key5794004
MDR Text Key50405349
Report Number8010762-2016-00450
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 07/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2017
Device Model NumberBEQ-HMOD70000-USA
Device Catalogue Number70105.3824
Device Lot Number70108123
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 Received07/07/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2015
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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