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

Lot Number 70073022

Device Problem Gradient Increase (1270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2012

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 1 of 3.(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4365274
• MDR Text Key: 5259232
• Report Number: 3008355164-2014-00385
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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
• Device Lot Number: 70073022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2012
• 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