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

Device Problem Gradient Increase (1270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

The customer reported that after 21 hours of therapy the membrane delta pressure increased to over 200 mmhg in a 45 min time frame.The oxygenator was changed out without any patient effects.The customer also reported that another patient had two oxygenators changed out for a similar scenario as above.No further details were provided for these events.This is device 2 of 3.(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365272
• MDR Text Key: 5289945
• Report Number: 3008355164-2014-00386
• 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: 12/17/2014,03/23/2012

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2012
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention