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

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).

• 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: 5794004
• MDR Text Key: 50405349
• Report Number: 8010762-2016-00450
• 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: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 70105.3824
• Device Lot Number: 70108123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Date Device Manufactured: 11/01/2015
• 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