MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC

Model Number BEQ-JMOD3000

Device Problem Gradient Increase (1270)

Patient Problem No Information (3190)

Event Date 03/25/2012

Event Type  Injury  

Event Description

The trans-membrane pressure began to increase soon after the oxygenator was put into use, and eventually required replacement due to continually rising high inlet pressures.(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365270
• MDR Text Key: 5266957
• Report Number: 3008355164-2014-00380
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2014,03/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-JMOD3000
• Device Catalogue Number: 70105-0330
• Device Lot Number: 70073702
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2012
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention