MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID AD.O.FIL

Model Number BEQ-HMOD70000

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2011

Event Type  Injury  

Event Description

Changed out oxygenator 20 minutes into a veno-veno ecmo case and noted blood leak from vent port at bottom of oxygenator.Described as "drip every 5 seconds and eventually stopped." the user decided to change the oxygenator, which was changed uneventfully.(b)(4).

• Brand Name: QUADROX-ID AD.O.FIL
• 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: 4365311
• MDR Text Key: 5289439
• Report Number: 3008355164-2014-00392
• 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: 12/17/2014,01/12/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD70000
• Device Catalogue Number: 70105.3824
• Device Lot Number: 70068187
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2012
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2012
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention