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

Model Number HMOD

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A product for investigation was not provided in reference to this complaint as the customer reported a generic statement.The reported observation had no patient effects.Clinical assessment: the customer was reporting about an partial very high pressure drop over the gas particle filter (which is included into the gas tube line which goes directly into the oxygenator).During the treatment a discrepancy between the preset gas flow and the actual gas exchange performance of the oxygenator was detected.The observed incident could have been caused likewise by the oxygenator or most probable by the gas particle filter itself.The gas particle filter is included into the oxygenator pack.Based on the information available at this time a confirmation of a product malfunction is not possible.The most probable cause of the reported observation is unknown.This failure was determined to be the first of its kind and is being handled through a designated mcp trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination of applicable investigation.Due to this no further action will be completed at this time.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.

Event Description

The customer is concerned that the pressure drop on sweep gas filter is sometimes very high.Do not know the cause.Requires very high sweep gas rate.The statement was not quantified and no patient effects.(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: 6842005
• MDR Text Key: 85112420
• Report Number: 8010762-2017-00285
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMOD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1