MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-1 ADULT

Model Number BQ HMOD 70000

Device Problems Occlusion Within Device (1423); Decrease in Pressure (1490)

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

Event Date 02/08/2013

Event Type  Injury  

Event Description

The customer asked me if we have a problem with adult softline quadrox d oxygenators clotting off.He said he has changed two of them out recently.He told me they were changed because he noticed an unexpected increase in the pressure drop.Flows were not affected by the change in pressure drop.(b)(4).

• Brand Name: QUADROX-1 ADULT
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365190
• MDR Text Key: 5114045
• Report Number: 3008355164-2014-00337
• 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: 12/15/2014,02/14/2013

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: BQ HMOD 70000
• Device Catalogue Number: 70105-3815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2013
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention